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FDA Recalls

October 2001 - August 7, 2002

Attention all mdi Clients:

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 7, 2002:

CLASS II

MANUFACTURER: Philips Medical Systems, Nederland B.V. Netherlands. Firm initiated recall is complete. Recalling Firm: Philips Medical Systems North America, Inc., Bothell, WA, by letter dated October 26, 2001.

PRODUCT: 1.5T MR Systems with software version R7.1.2 and higher: Magnetic Resonance Systems are indicated for use as diagnostic devices that produce transverse, sagital, coronal and oblique cross-sectional images, spectroscopic images and/or spectra based upon 1H and 31P metabolites, and that display the internal structure and/or function of the head, body or extremeties. These images and/or spectra, when interpreted by a trained physician, yeild information that may assist in diagnosis. The coils are used to obtain optimal imaging. Recall # Z-1147-2.

REASON: Higher than expected current in the insulation of the coil cable.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 26, 2002:

CLASS II

MANUFACTURER: Toshiba America Medical Systems, Inc., Tustin, CA, by letters dated February 22, 2002. Firm initiated recall is ongoing.

PRODUCT:NEMIO, SSA550A, Diagnostic Ultrasound System. Recall # Z-0923-2.

REASON: Software anomally caused error in calculating VM_P.

MANUFACTURER: Nellcor Puritan Bennett, Ireland, Ltd. Mervue, Galway, Ireland. Firm initiated recall is ongoing.

PRODUCT: Puritan Bennett-840 Ventilator System with optional compressor. Recall # Z-1040-2.

REASON: Failure of optional compressor on ventilator.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 19, 2002:

CLASS II

MANUFACTURER: Advanced Sterilization Products, Irvine, CA, by letters sent March 28, 2002. Firm initiated recall is ongoing.

PRODUCT:STERRAD 100S Sterilization System. Recall # Z-1082-2.

REASON: Software anomaly allows half cycle run when full cycle displayed.

MANUFACTURER: Gimelli Laboratories Co. Ltd., Shenzen Bao'An, Guangdong. Firm intiated recall is ongoing.

PRODUCT: Interplak power plaque remover toothbrush, battery operated toothbrush used to brush teeth and remove plaque.
Recall # Z-1104-2.

REASON: Batteries leaking hydrogen gas during charging popping off the end cap.

CLASS III

MANUFACTURER: Essex Industries, Inc., St. Louis, MO, by fax on February 22, March 26 and April 11, 2002. Firm initiated recall is ongoing.

PRODUCT: Invacare IRC 2121 Select Flow, CGS 870, 0-6L medical oxygen regulators. Recall # Z-1103-2.

REASON: Mislabeled as 0-6 LPM rather than 0-8 LPM.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 12, 2002:

CLASS II

****CORRECTION****

Recall # Z-1030-2 originally published in Enforcement Report 02-19 had an
incorrect recalling firm and notification date listed. It was listed as
Gambro Healthcare on April 9, 2000. The correct firm is Gambro Renal
products on April 9, 2002.

MANUFACTURER: I-Stat Corp., East Windsor, NJ, by letter dated April 22, 2002. Firm initiated recall is ongoing.

PRODUCT: Hematocrit and creatinine tests, as part of the i-STAT in-vitro diagnostic test system. Field Correction affected cartridges: i-STAT 6+, E3+, EC4+, EC6+, EC8+. Recall cartridges: Crea. Recall # Z-1083-2/Z-1087-2.

REASON: Erroneously high hematocrit results generated with cartridges.

MANUFACTURER: Unipath Ltd., Bedford, the United Kingdom. Firm initiated recall is ongoing. Recalled by Medpointe, Inc. (Wampole Laboratories Division), Cranbury, NJ, by fax on March 15, 2002.

PRODUCT: Clearview HCG II Pregnancy Test, Recall # Z-1089-2.

REASON: Sensitivity deterioration of pouched PRODUCT.

MANUFACTURER: Mitek products, Norwood, MA, by letter between January 17 and 18, 2002. Firm initiated recall is complete.

PRODUCT: Mitek Clearfix Meniscal Screw, 2 mm x 10 mm.
Recall # B-1090-2.

REASON: Meniscal screw may be out of specification and not deploy properly.

MANUFACTURER: Life-Tech Intl., Inc., Stafford, TX, by letter dated February 25, 2002. Firm initiated recall is ongoing.

PRODUCT: Brand name: Uropump Tube, Uropump Damping Chamber.
Recall # Z-1091-2/Z-1096-2.
The tube and chamber are sold stand-alone and in four kits, the Uropump Starter Kit, the Cavernosometry Starter Kit, and two different configurations of the Instrument Set Up Kit. When sold stand alone, the UPT is sold in a box of 50, and the UPDCC in a box of 25.

REASON: Device may not be sterile.

MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by urgent recall correction notification n April 24, 2002. Firm initiated recall is ongoing.

PRODUCT: Hill-Rom brand Affinity Three birthing bed.
Recall # Z-1097-2.

REASON: Bed may change position on its own.

MANUFACTURER: Heartport, Inc., Redwood City, CA, by letters on April 26, 2002. Firm initiated recall is ongoing.

PRODUCT: HEARTPORT Brand Arterial Cannulas described as follows:
Endo Return, 21 Fr.
Endo Return, 23 Fr.
Direct Flow, 24 Fr.
StraightShot, Angled, 23 Fr.
Arterial, 19 Fr. Recall # Z-1098-2/Z-1102-2.

REASON: A lap joint in certain arterial cannulas can separate.

CLASS III

MANUFACTURER: Stryker Trauma SA, Geneva, Switzerland. Firm initiated recall is complete.

PRODUCT: a) Monotube Triax Carbon Tube 15x200mm, Yellow, used for the stabilization of open and/or unstable fractures. Recall # Z-0769-2;
b) Monotube Triax Carbon Tube 15x150mm, Yellow.
Recall # Z-0770-2.

REASON: 200mm monotube length package actually contains a 150mm length monotube.

MANUFACTURER: Ortho-Clinical Diagnostics, Inc., Cardiff, Wales, the United Kingdom. Firm initiated recall is ongoing.

PRODUCT: VITROS Immunodiagnostics. Recall # Z-1088-2.
Free T3 Reagent Packs for in vitro diagnostic use.
100 test units per pack.

CAT 131 5589
Responsible firm on the label: Ortho-Clinical Diagnostics, Amersham, the United Kingdom.

REASON: Failure to include Supplemental Info. Sheet that contains updated values for Free Thyroid Control lots 60, 70 & 80.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 5, 2002:

CLASS I

MANUFACTURER: Pulmonetic Systems, Inc., Colton, CA, by letter on March 12, 2002. FDA initiated recall is ongoing.

PRODUCT: LTV Series Ventilators. Models:
a) LTV 1000 (cat. no. 10130), Recall # Z-1047-2;
b) Model LTV 950 (cat. no. 10950), Recall # Z-1048-2;
c) Model LTV 900 (cat. no. 10638), Recall # Z-1049-2;
d) Model LTV 800 (cat. no. 11800), Recall # Z-1050-2.

REASON: Shorts to inoperative condition.

CLASS II

MANUFACTURER: Synthes (USA), Monument, CO. Firm initiated recall is ongoing.

PRODUCT: Ti Cann Troch Fixation Nail. Trochanteric Fixation Nail. Recall # Z-1056-2/Z-1066-2.

REASON: Hole not properly centered.

MANUFACTURER: Hill-Rom Co. Inc., Batesville, IN, by letter beginning on April 30, 2002. Firm initiated recall is ongoing.

PRODUCT: Hill-Rom brand Horizon P100705 monitor slide. Recall # Z-1067-2.

REASON: Monitor may fall.

MANUFACTURER:Ballard Medical Products, Pocatello, ID. Firm initiated recall is ongoing.

PRODUCT:
a) Ballard Express Pre-Assembled Biliary Stent Systems. Recall # Z-1068-2;
b) Ballard Standard Biliary Stent Sets with and without guide wire. Recall # Z-1069-2;
c) Ballard Holland Biliary Stent Sets with and without guide wire. Recall # Z-1070-2;
d) Ballard Pancreatic Stent Sets with and without guide wire. Recall # Z-1071-2;
All sets are packaged in sterile 1-each package.

REASON: Stent anchor wings may not project, thereby failing to anchor stent.

MANUFACTURER: Portex, Inc., Keene, NH. Firm initiated recall is ongoing. Recalled by Sims Portex, Inc., Keene, NH, by letter on May 3, 2002.

PRODUCT: Portex Tracheostomy Tube, Laryngectomy tube, and Nasopharyngeal Airway products as follows:
Flex D.I.C.(TM) Trach Tubes, Product Number 504070 504080 504090 505070 505080 505090 505100. Recall # Z-1072-2;
D.I.C.(TM) Trach Tubes Product Number 502060 502080 502090 503060 503070 503080 503090 503100 512060 512080 512090 513070513080. Recall # Z-1073-2;
Laryngectomy Tube Product Number 562090. Recall # Z-1074-2;
Nasopharyngeal Airway Product Number 340060 340070 340080 340090. Recall # Z-1075-2;
Pediatric Trach Tubes Product Number 555030 555035 555040 555050 555055. Recall # Z-1076-2;
Per Fit (R) Percutaneous Trach Tubes Product Number 522070 522080 522090. Recall # Z-1077-2;
Lo Profile Trach Tube Product Number 592070. Recall # Z-1078-2;
Blue Line(R) Trach Tubes Product Number 508070 518070 518090 521070 521080 521090 530060 530070 530080 530090 531080 531100 550060 550070 550080 550090. Recall # Z-1079-2.

REASON: Product package may have defective seals and compromise sterility of device.

MANUFACTURER: Philips Medical Systems, fka: Picker International, Inc., Highland Heights, OH, by letter on April 8, 2002. Firm initiated recall is ongoing.

PRODUCT: AXIS/IRIX Gamma Camera System. A Prism XPVT System, Tomography, Computed, Emission, 90KPS System. Recall # Z-1080-2. Several catalog and serial numbers.

REASON: If the patient table is lowered onto a nearby object, such as a gurney, it may cause it to tip over.

CLASS III

MANUFACTURER: Arlanda Medicinska Instrument Co. AB, Sollentuna.
Firm initiated recall is complete.
Recalling Firm:
INRAD, Inc., Kentwood, MI, by telephone on April 18, 2002.

PRODUCT: INRAD brand Express core biopsy device, single use, disposable, sterile; 18 gauge x 15 cm. Catalog # 901518. Recall # Z-1081-2.

REASON: Extended expiration date on outer carton.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 29, 2002:

CLASS II

MANUFACTURER: EBI, l.p., Parsippany, NJ, by voluntary recall on March 6, 2002. Firm initiated recall is ongoing.

PRODUCT: EBI XFIX DFS OptiROM Elbow Fixator. Recall # Z-1035-2. The product is sold non-sterile and is packaged either in an inner foam liner aluminum metal casing or in plastic bag.

REASON: Pin migration at the connection of OptiROM central body and fixator.

MANUFACTURER: Genzyme Biosurgery, a division of Genzyme Corp., Fall River, MA, by letter dated April 3, 2002. Firm initiated recall is ongoing.

PRODUCT: Seprapack-Unilateral Application, sterile. (Bioresorbable nasal packing and sinus stent).

Recall # Z-1038-2.

REASON: Product packaging may have voids in the seal compromising sterility of device.

MANUFACTURER: Fisher Diagnostics Middletown, VA. Firm initiated recall is ongoing.

PRODUCT: Bayer Immuno 1(R) Troponin I Method.

Recall # Z-1039-2.

Common Name: Immuno 1(R) Troponin I Method.

REASON: Complaints received of low recoveries on Immuno 1 Troponin I Reagent Lot V60275.

MANUFACTURER: Nellcor Puritan Bennett Ireland, ltd. Mervue, Galway, Ireland. Firm initiated recall is ongoing.

PRODUCT: Puritan Bennett-840 Ventilator System with optional compressor. Recall # Z-1040-2.

REASON: Failure of optional compressor on ventilator.

MANUFACTURER: Hewlett Packard Company, Loveland, CO. Firm initiated recall is ongoing.

PRODUCT: a) Lightcycler microchemistry analyzer, catalog number

011468, printers. Recall # Z-1041-2;

b) Lightcycler microchemistry analyzer, catalog number 2043912, printers. Recall # Z-1042-2;

c) Lumi Imager microchemistry analyzer, catalog number 2012847, printers. Recall # Z-1043-2.

REASON: Printer power cord poses a shock hazard.

MANUFACTURER: ReGen Biologics, Inc., Redwood City, CA, by letters on April 16, 2002. Firm initiated recall is ongoing.

PRODUCT: Linvatec brand Double-Armed, Straight, Trocar Point 13” (33cm) Suture Needle Polyester, Green Braided, 36” (91.4cm) 2-0 U.S.P 3.0. metric. Recall # Z-1044-2.

REASON: Sterility may be compromised.

MANUFACTURER: Fujifilm Medical Systems U.S.A., Inc., Stamford, CT, by letter dated April 11, 2002. Firm initiated recall is ongoing.

PRODUCT: Synapse Image and Information Management System.

Recall # Z-1045-2.

REASON: Rotated/flipped Images not viewed on the screen may not rotate but left / right markers will be flipped.

MANUFACTURER: Liebel-Flarsheim Co., Cincinnati, OH. Firm initiated recall is ongoing.

PRODUCT: Liebel-Flarsheim Angiomat Illumena Media Power Injectors, P/N 900001, using Version 8.0 software with new console. Recall # Z-1046-2.

REASON: Pushing the scoll button repeatedly / rapidly results in erroneous protocol ID.

MANUFACTURER: Stryker Corp., Kalamazoo, MI, by letter dated April 26, 2002. Firm initiated recall is ongoing.

PRODUCT: Stryker Secure II hospital beds with an optional 110V outlet box assembly. Recall # Z-1055-2.

REASON: Shock hazard.

MANUFACTURER: Hemaedics, Inc., Brentwood, CA. Firm initiated recall is ongoing.

PRODUCT: Duoflo, Applicator Dispenser Kit, with Tisseal VH, Fibrin Sealant. Recall # Z-1053-2.

REASON: Tip breakage into surgical site.

CLASS III

MANUFACTURER: MPC/Geneva Medical Products, Prairie Du Chien, WI. Firm initiated recall is complete.

PRODUCT: a) 3T vent valves for perfusion circuits; sterile.

Recall # Z-1036-2;

b) 3T vent valves for perfusion circuits; non-sterile.

Recall # Z-1037-2.

REASON: Inadequate bond allows blood leakage or separation during use.

MANUFACTURER: Fuji Photo Optical Co. Ltd., Omiya, Saitama, 300-0036, Japan. Firm initiated recall is complete.

PRODUCT: EB-250S and EB-450S bronchoscope.

Recall # Z-1051-2/Z-1052-2.

REASON: During brochoscopy, suction valve stuck in active position.

MANUFACTURER: Dadson Mfg. Corp., Grain Valley, MO. Firm initiated recall is ongoing.

PRODUCT: Padgett Instruments, Inc. roller cylinder for the Mesh Skin Graft Expander, Model P-170, for use in producing a honeycomb pattern on the graft so it will expand. Recall # Z-1054-2.

REASON: The roller assembly might be defective.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 22, 2002:

CLASS II

MANUFACTURER: Invacare Corp., Elyria, OH, by certified mail on April 9, 2002. Firm initiated recall is ongoing.

PRODUCT: Invacare Reliant Scales, Models RSC600 and RSC600E. Recall # Z-1032-2/Z-1033-2.

REASON: The bolts that hold the scale to the lift may break and cause patient injury.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 15, 2002:

CLASS II

MANUFACTURER: Monaghan Medical Corp., Plattsburgh, NY, by letters dated March 20, 2002. Firm initiated recall is ongoing.

PRODUCT: AeroVent II Collapsible Holding Chamber (CHC) - for use in the administration of metered dose inhaler medications into a ventilator breathing circuit. Recall # Z-0992-2/Z-0994-2.

REASON: Collapsable Holding Chamber inadvertently opening.

MANUFACTURER: Amira Medical, Scotts Valley, CA. Firm initiated recall is ongoing. Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by addendum to labeling beginning December 17, 2001.

PRODUCT: Amira AtLast brand Blood Glucose Test System.

Recall # Z-0999-2.

REASON: Alternate site results not reliable when patient blood glucose level is low.

MANUFACTURER: Baxter Healthcare Corp., Cleveland, MS. Firm initiated recall is ongoing. Baxter Healthcare Corp., Round Lake, IL, by letters dated February 13, 2002.

PRODUCT: Baxter Interlink Solution Sets and Baxter Interlink Secondary Medication Sets which contain the BD Interlink Lever Lock Cannula; these sterile fluid paths are used for the administration of fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. 48 units per case. Recall # Z-1000-2/Z-1007-2.

REASON: Fluid leaks associated with BD Lever Lock cannulas.

MANUFACTURER: Siemens Medical Solutions, Erlangan, Germany. Firm initiated recall is ongoing. Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ, by letter on May 14, 2001.

PRODUCT: Somatom

Esprit, Esprit+, Balance, Emotion, Emotion Due, Volume Zoom, and Volume Access. Recall # Z-1010-2.

REASON: Errors occurring while using graphics tools.

MANUFACTURER: Nobel Biocare USA, Inc., Yorba Linda, CA, by telephone on March 12, 2002 and by letters on March 26, 2002. Firm initiated recall is ongoing.

PRODUCT: Steri-Oss Replace Select TiUnite Implant.

Recall # Z-1011-2.

REASON: Labeling mix-up.

MANUFACTURER: Laerdal Medical, Stavanger, Norway. Firm initiated recall is ongoing. Recalling Firm: Laerdal Medical Corp., Wappingers Falls, NY, by letters on March 29, 2002.

PRODUCT: Pressure Regulator Assembly (Cat. No. 85).

Recall # Z-1012-2.

This is a component part used in Infant and Child models of the Laerdal Silicone Resuscitator (LSR). It is also distributed in replacement patient valve assemblies, and as individual spare parts.

REASON: Molding irregularity in Pressure Regulator Cap, which could impede free movement of valve stem.

MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by notification on April 26, 2002. Firm initiated recall is ongoing.

PRODUCT: Hill-Rom brand Resident low bed, model 872.

Recall # Z-1014-2.

REASON: Pinched cables may cause arcing/shock hazard.

MANUFACTURER: Micro Therapeutics, Inc., Irvine, CA, by fax and e-mail on April 2, 2002. Firm initiated recall is ongoing.

PRODUCT: a) Model No. 105-5060 1.5 French FlowRider Micro Catheter. Recall # Z-1016-2;

b) Model No. 105-5063 1.8 French FlowRider Micro Catheter. Recall # Z-1017-2;

c) Model No. 105-5067 1.5 French FlowRider Plus Micro Catheter. Recall # Z-1018-2;

d) Model No. 105-5068 1.8 French FlowRider Plus Micro Catheter. Recall # Z-1019-2.

The difference between a FlowRider and FlowRider Plus is the presence of a silicone lubricant in the lumen of the FlowRider, which is, absent in the Plus.

REASON: Catheter rupture.

MANUFACTURER: Sunquest Information Systems, Inc., Tucson, AZ, by a workaround issued on April 1, 2002. Firm initiated recall is ongoing.

PRODUCT: Misys Laboratory Information System, Versions 5.23 and 5.3. Recall # Z-1020-2.

REASON: No QA Checking Performed on Differential Results.

MANUFACTURER: Longwell Electronics, Inc., Brea, CA. Firm initiated recall is ongoing. Beckman Coulter, Inc., Brea, CA, by product safety alert dated April 18, 2002.

PRODUCT: HP InkJet Printers connected as an accessory to a Beckman Coulter. Recall # Z-1022-2.

REASON: Printer Power Cord may cause shock to lab personnel.

MANUFACTURER: Medtronic Mexico, S. Del R.L. de C.V. Tijuana, BB. Firm initiated recall is ongoing. Medtronic Perfusion Systems, Minneapolis, MN, by, Urgent field action notice dated April 10, 2002.

PRODUCT: Medtronic Intersept Custom Tubing Packs.

Recall # Z-1023-2/Z-1029-2.

The packs are custom assembled for hospitals and each is identified with a product number. The product numbers and hospitals or distributors, for which the packs were assembled, are identified below:

Product number 0V67R10. Recall # Z-1023-2;

Made for: MERCY HOSPITAL, Des Moines, IA

Product number 1H22R2. Recall # Z-1024-2;

Made for: EXTRACORPOREAL ALLIANCE, Port Huron, MI

Product number 1H23R5. Recall # Z-1025-2;

Made for: EXTRACORPOREAL ALLIANCE, Pontiac, MI

Product number 1P82R3. Recall # Z-1026-2;

Made for: EXTRACORPOREAL ALLIANCE, Dearborn, MI

Product number 2D68R2. Recall # Z-1027-2;

Made for: PROVIDENCE MEDICAL CENTER, Kansas City, KS

Product number 2D81R. Recall # Z-1028-2;

Made for: COMPREHENSIVE PREFERRED CARE SVR, Buffalo, NY

Product number 5778R19. Recall # Z-1029-2.

Made for: HEALTH MIDWEST, Kansas City, MO

REASON: The vent valves in the recalled tubing packs may leak blood during cardiopulmonary bypass surgery, or the parts of the valves may separate, due to inadequate glue application.

MANUFACTURER: Gambro Dasco S.p.A. 41036, Medolla, Italy. Firm initiated recall is ongoing.

PRODUCT: Gambro Phoenix Hemodialysis System. Recall # Z-1030-2.

REASON: Incorrect measurement of dialysate conductivity due to electronic comp. failure.

CLASS III

MANUFACTURER: Becton Dickinson Infusion Therapy Systems, Inc., Sandy, UT, by telephone on September 20, 2001. Firm initiated recall is complete.

PRODUCT: BD MST Accessory Kit. Recall # Z-0997-2.

REASON: Kits labeled as containing 16 GA introducer actually contained 20 GA introducer.

MANUFACTURER: CryoLife, Inc., Kennesaw, GA, by visit on March 6, 2002. Firm initiated recall is complete.

PRODUCT: CryoValve Allograft, Recall # Z-1008-2.

REASON: Donor did not meet current guidelines regarding behavioral/social history.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by letter on March 8, 2002. Firm initiated recall is complete.

PRODUCT: CryoValve Allograft, Recall # Z-1009-2.

REASON: Donor did not meet current guidelines regarding behavioral/social history.

MANUFACTURER: Ortho-Clinical Diagnostics, Inc., Cardiff. Firm initiated recall is ongoing.

PRODUCT: Vitros Immunodiagnostics CEA (carcinoembryonic antigen) Calibrators. Recall # Z-1013-2.

REASON: Calibration failures/shift in QC results.

MANUFACTURER: Bioenterics Corp., Carpinteria, CA, by telephone on March 29, 2002 and by letters dated April 1, 2002. Firm initiated recall is complete.

PRODUCT: LAP Band

Sterile, Lap-Band Adjustable Banding System, 9.75cm and 10.0cm sizes. PMA# P000008 dated 6/5/01.

Recall # Z-1015-2.

The Lap-Band System is an inflatable silicone band that is laparoscopically placed around the upper part of the stomach to restrict how much food can be eaten at one time. It is indicated for use in weight reduction of severely obese patients.

REASON: Does not conform to PMA re: labeling.

MANUFACTURER: Di-Chem Concentrates, Inc., Lewisberry, PA. Firm initiated recall is complete. Recalling Firm: Gambro Healthcare, Deland, FL, by telephone on May 26 and 27, 1999, and letter dated June 1, 1999.

PRODUCT: 2-K AC-2409-D acid concentrate and bicarbonate dialysate, 55 Gallons, calcium 2.50 meq/l, etc.

Recall # Z-1021-2.

REASON: Calcium Concentrate was higher than the specified range.

MANUFACTURER: Abbott Laboratories, Inc., South Pasadena, CA, by letters on April 17, 2002. Firm initiated recall is ongoing.

PRODUCT: Aeroset Cholesterol Reagent. Recall # Z-1031-2.

REASON: Stability may be compromised over time, product currently OK.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 8, 2002:

CLASS II

*****CORRECTIONS*****

In the 02-06, February 13, 2002 Enforcement Report, Recall of Datascope Profile 8 French Intra-Aortic Balloon Catheters, PRODUCT numbers 0684-00-02971-01, 0684-00-0299-01, 0884-00-3441-01, and 0884-00-3441-02, has been assigned recall numbers Z-0518/0521-02.

In the 02-17, May 1, 2002 Enforcement Report, Recall of the Femoral Head Implant from the Foundation Hip System: Labeled in part:

"FOUNDATION***HIP SYSTEM ZIRCONIA FEMORAL HEAD***encore orthopedics",

Recall numbers Z-0895-2/Z-0899-2 was listed as ongoing, and should be listed as complete.

Recall of Invacare Mobilare Concentrators, 5 Liter, serial numbers 94K thru 94L, 95A thru 95L, 96A thru 96L, Recall numbers Z-0198-2/Z-0201-2 was originally listed as complete. It should be listed as ongoing.

MANUFACTURER: Invitrogen Corp., Grand Island, NY, by letters dated December 21, 2001. Firm initiated recall is ongoing.

RODUCT: GIBCO *** AIM-V Medium, for ex vivo activation of lymphocytes

-with L-glutamine

-with streptomycin @50 mcg/mL

-with gentamicin sulfate, USP @ 10 mcg/mL

-without penicillin G sodium. Recall # Z-0918-2.

Label states: "Check for product appearance before use. The performance characteristics of this product have not been officially established. It has not been approved to date for any human or animal in vivo applications except for certain investigational studies. ***"Sold in 1000 ml bottles and in 10L bags

REASON: Media fill failures.

MANUFACTURER: Ethicon, Inc., Juarez, Mexico. Firm initiated recall is complete. Ethicon, Inc., Somerville, NJ, by letters on February 10, 2002.

PRODUCT: Sterile Ethicon Gut Sutures. Recall # Z-0919-2-0921-2.

Brand Label: Chromic Surgical Gut Suture Plain Surgical Gut Suture Plain Fast Absorbing Suture

REASON: Secondary packaging has overwrap seal anomaly.

MANUFACTURER: Abbot Health PRODUCTs, Inc., Diagnostic Plant Barceloneta, Puerto Rico. Firm initiated recall is ongoing. Abbott Health PRODUCTs, Inc., Barceloneta, Puerto Rico, by letters dated March 26, 2002.

PRODUCT: a) AxSYM Digoxin II. Recall # Z-0956-2;

b) TDx/TDxFLx Digoxin II. Recall # Z-0957-2;

c) IMx Digoxin. Recall # Z-0958-2.

REASON: Assay may exhibit negative interference from aldosterone inhibitors.

MANUFACTURER: Medex, Inc., Dublin, OH, by telephone and fax beginning December 17, 2001. Firm initiated recall is ongoing.

PRODUCT: Medex Three-Way Anesthesia Style Stopcock with 20 inch, 33 inch, and 40 inch Extensions with Male Luer Locks and Male Luer Slips. Recall # Z-0986-2/Z-0990-2.

REASON: The tubing may separate from the stopcock during patient use.

MANUFACTURER: Sigma International Medina, NY, by letters between March 21 and 28, 2002. Firm initiated recall is ongoing.

PRODUCT: Sigma 8000 Volumetric Infusion Pumps with software version 3.50.01. Recall # Z-0991-2.

REASON: Software error: Distal occlusions may not be detected (no alarm) at rates above 550 ml/hr.

MANUFACTURER: Monaghan Medical Corp., Plattsburgh, NY, by letters dated March 20, 2002. Firm initiated recall is ongoing.

PRODUCT: AeroVent II Collapsible Holding Chamber (CHC) - for use in the administration of metered dose inhaler medications into a ventilator breathing circuit. Recall # Z-0992-2/Z-0994-2.

REASON: Collapsable Holding Chamber inadvertently opening.

CLASS III

****CORRECTION****

In the 02-17 Enforcement Report, Hydroview Brand Intraocular

Lens, Posterior Chamber Lenses, various diopters. Model Number H60M, Lot

Numbers 5YXP and 6R4B, Recall number Z-0933-2 was listed as ongoing and

should be listed as complete.

MANUFACTURER: Abbott Health PRODUCT, Inc., Diagnostic Plant Barceloneta, Puerto Rico. Firm initiated recall is ongoing.

PRODUCT: Prolactin Calibrators, Prolactin Controls, AxSYM and IMx Prolactin Reagents. Recall # Z-0950-2/Z-0953-2.

REASON: The concentration of Prolactin may have decreased by approx. 20%.

MANUFACTURER: Inrad, Inc., Kentwood, MI, by letter on February 16, 2000. Firm initiated recall is terminated.

PRODUCT: Inrad brand 2 part CHIBA type needle with accumark sheath, 15 cm., sterile. Recall # Z-0996-2.

REASON: 20 cm needle labeled as 15 cm needle.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 1, 2002:

CLASS I

MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letter dated March 20, 2002. Firm initiated recall is ongoing.

PRODUCT: a) Hill-Rom bassinet with dropleaf work surface & chart rack; Model 248. Recall # Z-0837-2;

b) Hill-Rom Clinical bassinet with dropleaf work surface & chart rack; model 1251. Recall # Z-0838-2.

REASON: Drop leaf work surface may fall down; won't support infant.

CLASS II

MANUFACTURER: Encore Orthopedics, Inc., Austin, TX, by telephone on August 16, 2001. Firm initiated recall is ongoing.

PRODUCT: The products are the femoral head implant from the Foundation Hip System. The products are labeled in part: "FOUNDATION***HIP SYSTEM ZIRCONIA FEMORAL HEAD***encore orthopedics". Each femoral head is packaged individually and labeled sterile.

Recall # Z-0895-2/Z-0899-2.

REASON: Femoral head component may fail.

MANUFACTURER: Smith & Nephew, Inc., Largo, FL, by letter on August 28, 2001. Firm initiated recall is complete.

PRODUCT: Covrsite Brand Wound Dressing, Part Numbers 59714100, 59714000 and 59714400. Recall #Z-900-2/Z-902-2.

REASON: Product was a wound dressing not adhering correctly.

MANUFACTURER: Exactech, Inc., Gainesville, FL, by letter on November 5, 2001. Firm initiated recall is ongoing.

PRODUCT: Optetrak Finned Cemented Tibial Tray (Total Knee Joint Replacement-tibial tray component). The device is intended to be implanted during a knee joint replacement surgery. Recall # Z-0903-2/Z-0904-2.

REASON: Device packaging may be mislabeled with the wrong size parts.

MANUFACTURER: Cordis Corp., Miami Lakes, FL, by letter on November 9, 2001. Firm initiated recall is ongoing.

PRODUCT: Raptor Rail PTCA Balloon Dilitation Catheter Catalog Numbers RR115, RR215 and RR315.

Recall # Z-905-2/Z-907-2.

REASON: Some of these catheters had a slower than desired deflation or no deflation.

MANUFACTURER: Exactech, Inc., Gainesville, FL, by telephone, fax and letters on December 17, 2001. Firm initiated recall is ongong.

PRODUCT: Exactech Brand Bipolar Hip Prosthesis, intended for use as an endoprosthesis in hemi-hip arthroplasty procedures.

a)Catalog # BP-2843, 43 mm OD Bipolar, 28mm ID,

Recall # Z-909-2;

b)Catalog # BP-2844, 44 mm OD Bipolar, 28mm ID,

Recall # Z-910-2.

REASON: The locking ring on the components is potentially assembled backwards.

MANUFACTURER: Ossur hf., Iceland. Firm initiated recall is ongoing.

OSSUR North America, Aliso Viejo, CA, by letters on February 27, 2002.

PRODUCT: Icelock ratchet UX 721, Model L-721000.

Recall # Z-0913-2.

Designed for use with ICEROSS silicone upper extremity liners for upper extremity amputees.

REASON: Pin does not stay engaged in lock mechanism.

MANUFACTURER: Sunquest Information systems, aka Misys Healthcare, Tucson, AZ. Firm initiated recall is ongoing.

PRODUCT: Misys Laboratory Microbiology Module,

Recall # Z-0916-2.

REASON: Software does not allow comments to be shown in some reports.

MANUFACTURER: Hitachi Ltd., Kbaraki-ken, Japan. Firm initiated

recall is ongoing.

PRODUCT: Roche Modular Analytics immunoassay based clinical chemistry analyzer, model E170, catalog number 7656961. Recall # Z-0922-2.

REASON: Possibility of false negative and false positive results being reported.

MANUFACTURER: Stryker Trauma GmbH D24232 Schoenkirchen, Germany. Firm initiated recall is complete.

Recalling Firm: Howmedica Osteonics Corp., Allendale, NJ, by letter on December 3, 2001.

PRODUCT: Condyle Screw Nut 1 x 05mm. Recall # Z-0927-2.

REASON: Torque on the condyle nut onto the condyle screw may be high. As a result the required compression of condyle fragments is not possible.

MANUFACTURER: Howmedica Osteonics Corp., Rutherford, NJ, by letters dated October 29, 2001.

Stryker Trauma GmbH D24232 Schoenkirchen, Germany.

Firm initiated recall is complete.

PRODUCT: Gamma Nail System Common Name: Gamma Locking Nail-Cross Locking Screws. Recall # Z-0928-2/Z-0929-2.

REASON: Mislabeling of the screw length on the outer package.

MANUFACTURER: Exactech, Inc., Gainesville, FL, by telephone and letters on May 21, 2001. Firm initiated recall is complete.

PRODUCT: Total Knee Augnentation Block Implants.

Recall # Z-0931-2.

REASON: Compromise of sterility barrier packaging.

MANUFACTURER: Medtronic Xomed Jacksonville, FL, by telephone and fax August 30, 2001. Firm initiated recall is ongoing.

PRODUCT: Laser Guard Endotracheal Tube Protector.

Recall # Z-0932-2.

REASON: The Endotracheal Tube Silver Foil wrap may develop breaks when manipulated. Potential for overheating or fire.

MANUFACTURER: Ecolab Inc., Huntington, IN, by letter dated January 17, 2002. Firm initiated recall is ongoing.

PRODUCT: Cida-Steryl 28 II 3% Glutaraldehyde.

Recall # Z-0935-2.

REASON: May not effectively sterilize devices.

MANUFACTURER: Cordis Corp., Miami Lakes, FL, by letter on December 7, 2001. Firm initiated recall is ongoing.

PRODUCT: BX Velocity Balloon Expandable Stent, (common name is Coronary Stent and Delivery System, 8mm X 2.75, Sterile. Recall #Z-0936-2.

REASON: Stents could migrate from their original crimped position on the delivery system.

MANUFACTURER: Cardiodynamics International Corp., San Diego, CA, by letter the week of January 14, 2002. Firm initiated recall is complete.

PRODUCT: BioZ.com Hemodynamic Monitor Impedance Plethysmograph.

Recall # Z-0937/Z-0938.

REASON: Improper responses with pacemaker patients.

MANUFACTURER: Recalling Firm: Pentax Precision Instrument Corp.,

Orangeburg, NY, by letters dated March 14, 2002.

Firm initiated recall is ongoing.

PRODUCT: a) Video Bronchoscope, Model EB-1530T3, Device Listing #A845585. Classification: EOQ, Bronchoscope, CFR 874.4680. Recall # Z-0939-2;

b) Video Gastroscope, Model #EG-1540, Device Listing #A845591. Classification: FDS, Gastroscope, CFR 876.1500. Recall # Z-0940-2.

c) Video Esophagoscope, Model #EE-1540, Device Listing #A845597. Classification: GCL, Esophagoscope, CFR 876.1500. Recall # Z-0941-2.

REASON: Lubricant leaking from bronchoscope caused by puncture at the point where the instrument channel is secured to the distal end.

MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letter dated April 2002. Firm initiated recall is ongoing.

PRODUCT: Recall # Z-0942-2/Z-0946-2.

a) Hill-Rom brand TranStar Electric Stretcher;

b) Hill-Rom brand TranStar OB/GYN Stretcher;

c) Hill-Rom brand TranStar Procedural Stretcher;

d) Hill-Rom brand TranStar Surgical Stretcher;

e) Hill-Rom brand TranStar Trauma Stretcher;

f) Hill-Rom brand Durastar Hydraulic Stretcher.

REASON: May leak hydraulic fluid.

MANUFACTURER: Hill-Rom Co. Inc., Batesville, IN, by letter on April 8, 2002. Firm initiated recall is ongoing.

PRODUCT: Hill-Rom Exam Plus lights, catalog numbers P965-00 and P965-01. Recall # Z-0947-2/Z-0948-2.

REASON: Incorrectly labeled for use during surgical Procedures.

MANUFACTURER: Steris Corp., Mentor, OH, by telephone on March 19 and 20 and by letter on March 21, 2002. Firm initiated recall is ongoing.

PRODUCT: Double Port Flow Adapter, STERIS Part Number 200388.

Recall # Z-0949-2.

1) Sold as a component of STERIS Quick Connect Kit #C1460;

2) Also sold individually as a replacement component.

REASON: Adapter ports may be obstructed with glue, and affect the sterilization process.

MANUFACTURER: Recalling Firm: Philips Medical Systems North America, Inc., Bothell, WA, by letter dated March 29, 2002. Firm initiated recall is ongoing.

PRODUCT: Omni-Diagnost X-Ray System, fluoroscopic x-ray system: multifunctional, universal, overtable x-ray system offering fluroscopic, radiographic, angiographic and interventional techniques in a wide variety of applications. Recall # Z-0959-2.

REASON: The scan carriage may collide with the patient's knees.

MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by urgent product correction dated April 15, 2002. Firm initiated recall is ongoing.

PRODUCT: All DataCare Systems Software, as follows:

Recall # Z-0960-2/Z-0974-2.

a) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9200;

b) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9201;

c) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog BP9251;

d) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog BP9252;

e) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9200;

f) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9201;

g) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9206;

h) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9207;

i) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9208;

j) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog BP9251;

k) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog BP9252;

l) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9202;

m) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9209;

n) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9010;

o) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9211;

p) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9212

q) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog BP9215;

r) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog BP9216.

REASON: Potential patient/sample mismatch.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by letter on April 1, 2002. Firm initiated recall is complete.

PRODUCT: CryoValve Allograft. Recall # Z-0981-2.

REASON: Serodilution of plasma.

MANUFACTURER: MK Manufacturing Forestville, CT. Firm initiated recall is ongoing. Recalling Firm: Instrumentation Industries, Inc., Bethel Park, PA, by telephone and letters on March 22, 2002.

PRODUCT: Steel Oxygen Wrench. The device is a Class I steel oxygen wrench.

a) Catalog number 169 has a security wire attached to the wrench.

b) Catalog number 169W does not have the wire.

Recall # Z-0982-2/Z-0983-2.

REASON: Slots may not be big enough to fit on E tanks.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by telephone on April 8, 2002. Firm initiated recall is complete.

PRODUCT: CryoValve Allograft - Heart Valve. Recall # Z-0984-2.

REASON: Serodilution of Plasma.

CLASS III

MANUFACTURER: Boin Medica Co., Inc, Kumi City, Kyungbuk, Korea.

Firm initiated recall is ongoing. Becton Dickinson & Co. Franklin Lakes, NJ, by e-mail on January 11, 2002.

PRODUCT: Brand Name: Walgreens Sterile Insulin syringes, single use, disposable, 0.3cc and 1.0cc 29 Gauge. Recall # Z-0911-2/Z-0912-2.

REASON: Mispackaged syringes; 3/30cc syringes into 1.0cc syringe boxes.

MANUFACTURER: Philips Medical Systems Nederland, B.V. Netherlands. Firm initiated recall is ongoing. Philips Medical Systems North America Company, Bothell, WA, by communication on December 4, 2001.

PRODUCT: Gyroscan NT System, MRI. Recall # Z-0917-2.

REASON: Potential for misdiagnosis. When two images were subtracted, one with contrast and the other without contrast, irregular vessels could be the result on the final image.

MANUFACTURER: Philips Medical Systems Nederland, B.V. 5680 DA Best, Netherlands. Firm initiated recall is ongoing. Philips Medical Systems North America, Inc., Bothell, WA, by letter dated November 14, 2001.,

PRODUCT: Integris H5000, Angiographic X-ray system.

Recall # Z-0924-2.

REASON: System may occasionally re-boot during a patient examination.

MANUFACTURER: Roche Diagnostics Corp., Mannheim, Germany. Firm initiated recall is ongoing. Roche Diagnostics Corp., Indianapolis, IN, by letter dated April 5, 2002.

PRODUCT: LightCycler v1.0; catalog # 2011468. Recall # Z-0925-2

LightCycler v1.1; catalog # 2043912.Recall # Z-0926-2. The device is a medium-sized polymerase chain reaction analyzer for use in industrial, laboratory and domestic setting.

REASON: Glass capillary breakage.

MANUFACTURER: Bausch & Lomb Surgical, Inc., Clearwater, FL, by letter beginning August 31, 2001. Firm initiated recall is ongoing.

PRODUCT: Hydroview brand Intraocular Lens, Posterior chamber lenses, various diopters. Recall # Z-0933-2.

REASON: Lenses were labeled with incorrect dioptic powers.

MANUFACTURER: Macropore, Inc., San Diego, CA, by letter on December 7, 2001. Firm initiated recall is ongoing.

PRODUCT: MacroPore NS CraniLoc Burr Hole Clamp. This is a part of the CraniLoc Cranial Flap Fixation System. Catalog Number: 6692599.

Recall # Z-0934-2.

REASON: Loosening and breakage.

MANUFACTURER: Phillips Medical Systems Nederland, B.V. 5680 DA BEST,

Netherlands. Firm initiated recall is ongoing. Philips Medical Systems North America Company, Bothell, WA, by Field Change Order dated September 2001.

PRODUCT: GYROSCAN NT SYSTEM, MRI - Magnetic Resonance Systems.

Recall # Z-0955-2.

REASON: Potential for tabletop (bed) to slide.

MANUFACTURER: Acumed, Inc., Hillsboro, OR, by fax, e-mail or letter on March 7, 2002. Firm initiated recall is complete.

PRODUCT: a) Polarus Humeral Rod, part #HRH-0824-S, 8mm x 240mm.

Recall # Z-0978-2.

b) Polarus Humeral Rod, part #HRH-0826-S, 8mm x 260mm.

Recall # /Z-0979-2.

These implants belong to the Polarus Humeral Rod System product line which is a system of rods and screws for the fixation of humeral fractures and their accompanying instrumentation.

REASON: Mislabeled - 240mm Polarus rod labeled as 260mm Polarus rod & vice versa.

MANUFACTURER: Ciba Vision Batam Pulau Batam, Indonesia. Firm initiated recall is ongoing.

MANUFACTURER: Ciba Vision Batam Pulau Batam, Indonesia. Firm initiated recall is ongoing.

PRODUCT: Precision UV (ultraviolet blocking) daily or extended wear soft (hydrophilic) contact lens.

Recall # Z-0980-2.

REASON: Product was distributed without the proper labeling.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of
April 24, 2002:

CLASS I

MANUFACTURER: Zoll Medical Corp., Burlington, MA, by letter on December 18, 2001. Firm initiated recall is ongoing.

PRODUCT: a) Zoll M Series Advisory Defibrillator.

Recall # Z-0893-2;

b) Zoll M Series AED Defibrillator (semi automatic defibrillator). Recall # Z-0894-2.

REASON: Defibrillator may fail to detect ventricular fibrillation and fail to deliver shock.

CLASS II

CORRECTION

On the April 3, 2002 Enforcement Report, Recall # Z 596-2, DynaGraft Gel and Putty, a mixture of human demineralized allograft bone powder mixed with a reverse-phase medium and formulated into a gel or putty consistency was listed as a Class III and it is a Class II.

MANUFACTURER: Guidant Corp., Temecula, CA, by visit, phone and fax on January 29, 2002. Firm initiated recall is complete.

PRODUCT: a) Hi Torque Balance Middle Weight Guide Wire.

Recall # Z-0828-2;

b) Dock Extension Wire. Recall # Z-0829-2.

Guide Wires intended to facilitate the placement of balloon dilation catheters during percutaneous transluminal angioplasty.

REASON: Sterility compromised.

MANUFACTURER: Datascope Corp., Mahwah, NJ, by mail on January 17, 2002. Firm initiated recall is ongoing.

PRODUCT: Passport 2/Passport 2 LT Vital Signs Monitor. Multi-parameter patient monitoring system.

Recall # Z-0830-2.

REASON: Power Supply problems for the monitor may shut down without notice.

MANUFACTURER: Integra Neurocare LLC., San Diego, CA, by letter dated March 8, 2002. Firm initiated recall is ongoing.

PRODUCT: Ventrix NL950-V Ventricular Tunneling Pressure Monitoring Kit; consists of a sterile, transducer tipped catheter that is used to continuously monitor intracranial pressure and drain cerebrospinal fluid. Kit includes a trocar, introducer stylet, suture loops, a drill bit and hex wrench. Recall #Z-0831-2.

REASON: Directions have blank pages.

MANUFACTURER: Portex, Inc., Keene, NH, by letter on March 19, 2002.

Firm initiated recall is ongoing.

PRODUCT: Portex Hypodermic NEEDLE-PRO Needle with Needle Protection Device (Small Gauge Safety), Sterile:

a) Catalog No. 4320 (25g x 5/8"). Recall # Z-0832-2;

b) Catalog No. 4322 (26g x 1/2"). Recall # Z-0833-2;

c) Catalog No. 4323 (27g x 1/2"). Recall # Z-0834-2.

REASON: Sterility of the device may be compromised due to a loss of package integrity.

MANUFACTURER: Ciba Vision Corp. Duluth, GA, by telephone on March 1, 2002. Firm initiated recall is ongoing.

PRODUCT: SoftPerm Daily Wear Soft (Hydrophilic) Contact Lens. Recall # Z-0835-2.

REASON: Improper sterilization cycle.

MANUFACTURER: Medi-Tech a division of Boston Scientific Corp., Watertown, MA. Firm initiated recall is complete.

PRODUCT: Boston Scientific/Medi-Tech RENEGADE Hi-Flo Microcatheter Kit. Recall # Z-0836-2.

REASON: Kit packaged with an incorrect quidewire length of 135 cm instead of 165 cm.

MANUFACTURER: Cordia Europa Roden, Netherlands.

Firm initiated recall is ongoing.

PRODUCT: Cordis Temp 4F Diagnostic Catheter WITH THE FOLLOWING CATALOG NUMBERS OR ITEM NUMBERS (SEE CODES SECTION FOR CORRESPONDING LOT NUMBERS UNDER RECALL): 451406H0, 451406H2, 451406P0, 451406P2, 451406S0, 451406S2, 451406V0, 451407H2, 451407S2, 451407V0, 451413H0, 451413V0, 451414H0, 451415H0, 451415V0, 451423H0, 451424H0, 451425H0, 451430H0, 451430H2, 451431H0, 451431H2, 451432H0, 451435H0, 451442V0, 451442V2, 451443H0, 451443V0, 451443V2, 451444V0, 451444V2, 451446S0, 451446V2, 451447S0, 451447S2, 451449V0, 451450V0, 451457V0, Total Items38

Recall # Z-0839-2-0876-2.

REASON: Instances of catheter tip separation.

MANUFACTURER: HemoCleanse, Inc., Rochester, NY. Firm initiated recall is ongoing.

PRODUCT: Liver Dialysis Unit: Treatment Kit/Disposable Pack. Recall # Z-0877-2. This is a disposable, single use kit used during dialysis.

REASON: The filtrate generator was installed backwards, causing tension and crimping in the tubing line.

MANUFACTURER: UMM Electronics Inc., Indianapolis, IN. Firm initiated recall is ongoing.

PRODUCT: Liver Dialysis Unit Machine (LDU1) and Treatment Kits. Recall # Z-0878-2.

REASON: Electronic controller board overheats causing alarm and device failure.

MANUFACTURER: Stryker Trauma GmbH, D24232 Schoenkirchen, Germany.

Firm initiated recall is complete.

PRODUCT: Gray Tip Drill, 1 x 0.126 x 8". Recall # Z-0879-2.

REASON: Gray Tip Drill mislabeled as lag screw.

MANUFACTURER: UMM Electronics, Inc., Indianapolis, IN. Firm initiated recall is complete.

PRODUCT: Liver Dialysis Unit Machines and kits. (aka LDU2) Product was previously named BioLogic DT System with BioLogic DT TK1000 kits. Recall # Z-0880-2.

REASON: Units alarm and shut down for unexplained reason.

MANUFACTURER: Drager Medical AG & Co KGaA Lubeck, Germany.

Firm initiated recall is ongoing.

PRODUCT: Caleo Infant Warming System. The product is an incubator. The device provides access for minor surgical procedures and allows endotracheal incubation without having to slide the baby out of the incubator. Recall # Z-0881-2/Z-0885-2.

REASON: May short circuit.

MANUFACTURER: Acumed, Inc., Beaverton, OR, by fax or e-mail on January 31, 2002. Firm initiated recall is complete.

PRODUCT: a) Polarus Humeral Rod System, part #HCO3275-S, 3.5mm x 27.5mm b) Cortical Screw, and part #HCO3325-S, 3.5mm x 32.5mm Cortical Screw. The Polarus Humeral Rod System is a system of rods and screws for the fixation of humeral fractures and their accompanying instrumentation. Recall # Z-0886-2/Z-0887-2.

REASON: Extended sterilization expiration date.

MANUFACTURER: Sunquest Information Systems, Inc., aka Misys Healthcare Systems Tucson, AZ, by a temporary procedural workaround March 8, 2002. Firm initiated recall is ongoing.

PRODUCT: Misys Laboratory for Windows version 5.3.

Recall # Z-0888-2.

REASON: Software QA code of BOTH for patient sex can result in QA flags not being generated for abnormal results.

MANUFACTURER: Avanta Orthopaedics, Inc., San Diego, CA, by telephone on March 14, 2002. Firm initiated recall is complete.

PRODUCT: Avanta Orthopaedics, Proximal Radial Head Stem, Product Code RHA-S2, Lot RS0099. Recall # Z-0889-2.

REASON: Label mix-up. Incorrect size on label.

MANUFACTURER: Philips Medical Systems Nederland, B.V. 5680 Da Best, Netherlands. Firm initiated recall is ongoing.

PRODUCT: a) Integris Allura X-ray system with Ultrasound option. The Integris Alluras x-ray system is used as an imaging device for: dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures; cardiac imaging applications including diagnostics, interventional procedures, pacemaker implantations, and electrophysiology; non-vascular interventions such as drainage and biopsies. Recall # Z-0890-2;

b) MultiDiagnost 3 with Ultrasound Option.

Recall # Z-0891-2

c) MultiDiagnost 4 with Ultrasound Option. The MultiDiagnost 3 and MultiDiagnost 4 are multi functional/universal systems used for general R/F. Fluoroscopy, Radiography and Angiography can be performed with other specialized interventional applications. The ultrasound system is used for diagnostic ultrasound imaging or fluid flow analysis of the human body. Recall # Z-0892-2.

REASON: Potential for supporting arm and keyboard to strike patient.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of
April 17, 2002:

CLASS I

MANUFACTURER: A & A Medical/Rocket USA, (also labeled Lifequest), Alpharetta, GA, by letter on March 13, 2002. Firm initiated recall is ongoing.

PRODUCT: Various OB/GYN surgical devices labeled as sterile or processed by ETO. Recall # Z-0597-2.

REASON: Devices may not have been adequately sterilized.

MANUFACTURER: Proximal Inc., Largo, FL. Firm initiated recall is ongoing.

PRODUCT: Bard RapidFire Multiple Band Ligator.

Recall # Z-0755-2.

REASON: Band Ligator may fail to deploy and prevent control of bleeding.

CLASS II

MANUFACTURER: Fresenius Hemocare, Inc., Redmond, WA, by letters dated September 20, 2001. Firm initiated recall is complete.

PRODUCT: PROSORBA Protein A Immunoadsorption Column - indicated for use in the therapeutic removal of immunoglobulin G (IgG) and IgG-containing circulating immune complexes from plasma in patients with idiopathic thromocytopenic purpura (ITP) having patelet counts less than 100,00mm3. The Prosorba column is indicated for use in the therapeutic reduction of the signs and symptoms of moderate to severe rheumatoid arthritis in adult patients with long standing disease who have failed or are intolerant to disease-modifying anti-rheumatic drugs (DMARDS).

Recall # Z-0782-2.

REASON: Increased potential to develop vasculitis.

MANUFACTURER: Avent SA de CV Nogales, Sonora, Mexico. Firm initiated recall is ongoing.

PRODUCT: a) ORTHOARTS Lower Extremity Drape, Bulk Pack, Non-sterile;

b) ORTHOARTS Lower Extremity Drape, Sterile;

c) ORTHOARTS Lower Extremity Pack, Sterile;

d) ORTHOARTS Hip Drape, Bulk Pack, Non-sterile;

e) ORTHOARTS Hip Drape, Sterile;

f) ORTHOARTS Hip Pack, Sterile;

g) ORTHOARTS Knee Arthroscopy Drape, bulk, non-sterile;

h) ORTHOARTS Knee Arthroscopy Drape, sterile;

i) ORTHOARTS Knee Arthroscopy Pack;

j) Canton-Potsdam Lower Extremity Pack;

k) Mercer Orthopedic II Pack;

l) ORTHOARTS Lower Extremity Pack;

m) Sharon Regional Total Knee Pack.

Recall # Z-0784-2/Z-0796-2.

REASON: The fenestrated elastic film can separate from drape causing a break in sterility.

MANUFACTURER: Implant Innovations, Inc., Palm Beach Gardens, FL, by telephone on Feb. 21, 2002. Firm initiated recall is complete.

PRODUCT: HA threaded Implant 4.0mm X13.0mm Sterile Endosseous Implants for use in Dental Implant Surgery.

Recall # Z-0798-2.

REASON: Implants may not have the labeled hydroxylapatite coating.

MANUFACTURER: First Aid Only, Vancouver, WA, by telephone in Sept. 2001. FDA initiated recall is complete.

PRODUCT: First Aid Only All Purpose First Aid Kit (Item# FA-143C). Recall # Z-0799-2.

REASON: First aid kits were made using a recalled antiseptic spray that may be subpotent.

MANUFACTURER: Visualization Technology, Inc., Lawrence, MA, by letter on Feb. 20, 2002. Firm initiated recall is ongoing.

PRODUCT: InstaTrak Adult Headset (Part No 1000497). Recall # Z-0800-2; InstaTrak Large Pediatric (Part No 1000948). Recall # Z-0801-2;

InstaTrak Small Pediatric (Part No 1000949). Recall # Z-0802-2. The InstaTrak system is intended as an aid to the surgeon for precisely locating anatomical structures anywhere in the human body during either open or percutaneous procedures.

REASON: Use of headset in a rotated position may result in undetected system inaccuracy.

MANUFACTURER: Misys Healthcare Systems, Tuscon, AZ, by notice on March 8, 2002. Firm initiated recall is ongoing.

PRODUCT: Misys Laboratory (formerly FlexiLab) information system. Recall # Z-0803-2.

REASON: Software anomaly may allow patient results to be transposed against another patient header or identification.

MANUFACTURER: Medtronic, Inc., Minneapolis, MN, by letter dated March 15, 2002. Firm initiated recall is ongoing.

PRODUCT: Kappa 700/600 Dual Chamber (D, DR, and VDD) Implantable Pulse Generator Pacemakers, Models KD700, KD701, KD703, KD706, KDR600, KDR601, KDR603, KDR606, KDR651, KDR653, KDR700, KDR701, KDR703, KDR706, KDR720, KDR721, KDR730, KDR731, KDR733, KVDD700, and KVDD701. Recall # Z-0804-2/Z-0823-2.

REASON: Submuscular implant locations (subpectoral, abdominal, etc.) can result in additional stress and repetitive flexing on the implanted pacemaker, causing excessive fatigue and fracture of internal wires supplying power to the pacemaker.

MANUFACTURER: EURO/DPC, Ltd. Wales, The United Kingdom. Firm initiated recall is ongoing.

PRODUCT: Brand Name: IMMULITE 2000 Anti-Thyroglobulin Antibody Common/ Usual Name: IMMULITE 2000 Anti-Thyroglobulin Antibody, Intended for the quantitative measurement of autoantibodies to Thyroglobulin in serum EDTA and heparinized plasma. Recall #Z-0824-2.

REASON: Insufficient stability at certain temperatures causes control values to be high.

MANUFACTURER: Diagnostic Products Corp., Los Angeles, CA, by telehone on January 30, 2002. Firm initiated recall is ongoing.

PRODUCT: Brand/Common/Usual Name of Device: IMMULITE Anti-TPO

This is an in-vitro diagnostic device. It is supplied in 100 and 500 test kits. Model/catalog numbers are: 100 test: LKT01 175 500 test: LKT05 175.

Recall # Z-0825-2.

REASON: Instability caused positively biased control values.

MANUFACTURER: DeRoyal Surgical, New Tazewell, TN. Firm initiated recall is ongoing.

PRODUCT: DeRoyal Vasectomy Tray, a surgical kit, P/N 50-9112. Recall # Z-0826-2.

REASON: Surgical kits contained recalled Ethicon sutures.

MANUFACTURER: Spembly Medical Ltd., England. Firm initiated recall is ongoing.

PRODUCT: Selector Ultrasonic Surgical Aspirator System; affected part is the Selector Integra Ultrasonic Aspirator Operator's Manual, Part Number: OM 1530000M1; Issue C168-4. Recall # Z-0827-2.

REASON: Directions cite Euro approved not US approved sterilization cycle parameters.

CLASS III

MANUFACTURER: Diagnostic Stago, Taverny, France. Firm initiated recall is ongoing.

PRODUCT: STA-Deficient VIII Immuno-depleted Plasma for Factor VIII: C Assay by STA Analyzers. Recall # Z-0781-2.

REASON: Gradual decline in stability of the reagent after reconstitution.

MANUFACTURER: Louisville APL Diagnostics, Inc., Doraville, GA, by telephone on August 16, 2001. Firm initiated recall is complete.

PRODUCT: Immuclone APhL ELISA Kit (IgG and IgM) calibrators.

Recall # Z-0783-2.

REASON: IgG and IgM calibrators took too long for color reactions.

MANUFACTURER: Cfh Laboratories, L.P., Morris Plains, NJ.

Firm initiated recall is ongoing.

PRODUCT: Unizyme, Recall # Z-0797-2.

REASON: Contamination with brass particles from the tablet press.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of
April 10, 2002:

CLASS II

MANUFACTURER: Cardiovascular Diagnostics, Inc., d/b/a Pharmanetics, Inc., Morrisville, NC. Firm initiated recall is complete.

PRODUCT: PT-One Cards. Recall # Z-0678-2.

REASON: Incorrect inserts were found in some boxes of the product.

MANUFACTURER: Asahi Optical Co., Ltd. (AOC) Tokyo, Japan.

FDA initiated recall is ongoing.

PRODUCT: Pentax brand Video Colonoscopes and Fiber Colonoscopes. The Angle Wire Receptacle component is the affected part. Recall # Z-0680-2/Z-0681-2. Common Names: Video Colonoscope; Fiber Colonoscope Classification Name: Colonoscope (CFR 876.1500).

REASON: Angle Wire Connecting Receptacle component was observed to be cracking, resulting in a loss of angulation control for the direction in which the part was applied (up, down).

MANUFACTURER: Electric Mobility Corp., Sewell, NJ, by e-mail, letter and notice on January 7, 2002. Firm initiated recall is ongoing.

PRODUCT: Small power chairs and TurnAbout power chairs (510(k) # 972370). Recall # Z-0700-2/Z-0701-2.

The small power chairs include the following product names: Chauffeur Littlest Viva, Chauffeur Littlest Viva Plus, Rascal Model 250, Rascal Model 255, Rascal Model 410, Rascal Model 415, Chauffeur Model 250 and Chauffeur Model 255. The TurnAbout power chairs include the following product names: TurnAbout and TurnAbout Heavy Duty.

These power chairs are personal motorized vehicles intended to provide mobility for individuals, such as the handicapped and the elderly, who are limited in movement.

The power chairs are shipped either covered in plastic or in a brown cardboard unit container labeled with “**MADE WITH PRIDE IN THE USA. *ELECTRIC MOBILITY**”.

The products are labeled with stick-on labels. Labeling information follows.

1. Chauffeur Littlest Viva models are labeled as:

a) “LITTLEST VIVA” in black letters on silver background; and b) “Chauffeur mobility” in silver letters, except for the second “f” which is red, outlined in black on a silver background. The Littlest Viva Plus is also labeled with “plus” in black letters on a silver background.

2. Rascal models are labeled as:

a) “ELECTRIC MOBILITY in gold letters; b) “Rascal” in gold letters; and, depending on the model number, c) either “250 PC”, “255 PC”, “4 10 PC”, or “415 PC” in gold letters.

3. Chauffeur models are labeled as:

a) “Chauffeur mobility” in silver letters, except for the second “f” which is red, outlined in black on a silver background; and, depending on the model number, b) either “250 PC” or “255 PC” in black on a silver background.

4. TurnAbout models are labeled as:

a) “ELECTRIC MOBILITY in gold letters; and

b) “TurnAbout***by Rascal” in gold letters.

REASON: The wheel bolt can loosen and cause the wheel to separate from chair.

MANUFACTURER: Baxter Healthcare Corp. Singapore, SG.

Firm initiated recall is complete.

PRODUCT: Interlink System Continu-Flo Solution Set, 10 drops/ml. approximately, 110" (2.8m), with 3 injection sites and a male luer lock adapter; product code 2C6537W. Recall # Z-0704-2.

REASON: Retrograde flow during direct injection.

MANUFACTURER: Bio-Rad Laboratories, Inc., West Sacramento, CA, by telephone and fax on Jan. 25, 2002. Firm initiated recall is ongoing.

PRODUCT: Helix Diagnostics, Enzyme Immunoassay Helicobacter pylori H. pylori) IgM Test Kits. Recall # Z-0705-2.

REASON: Device marketed without a 510(k) or PMA.

MANUFACTURER: Haemonetics Corp., Braintree, MA, by letter on January 25, 2002. Firm initiated recall is ongoing.

PRODUCT: Haemonetics PCS2 Harness Set, Sterile List Number:620. Recall # Z-0706-2.

REASON: Potential leakage at needle adapter site may expose user to donor blood.

MANUFACTURER: Sunquest Information Systems, Inc., Tucson, AZ

PRODUCT: FlexiLab Laboratory Information System. Recall # Z-0710-2.

REASON: Date Format Issue--Flexilab Software converts specimen collect and receipt dates to American standard format 'mm/dd/yyyy'. For sites using the Euro date format this can alter the generation of QA warnings or flags based on collect or receipt date.

MANUFACTURER: ANSYS Technologies Inc., Lake Forest, CA. Firm initiated recall is ongoing.

PRODUCT: On-Site Alcohol test kit. Recall # Z-0711-2.

REASON: False negative results or false positive may be reported.

MANUFACTURER: Sims Deltec, Inc. St. Paul, MN, by notification dated Feb. 6, 2002. Firm initiated recall is ongoing.

PRODUCT: PORT-A-CATH II Dual-Lumen Low Profile

Polysulfone/Titanium (Implantable) Venous Access System, with 1.0mm I.D PolyFlow Polyurethane Catheter and 7 French Introducer Set.

Recall # Z-0712-2/0713-2.

REASON: The Wing-Lock catheter connectors of some of the devices will not snap into place as described in the Instructions for Use.

MANUFACTURER: Possis Medical, Inc., Minneapolis, MN, by letter dated February 8, 2002. Firm initiated recall is ongoing.

PRODUCT: AngioJet Drive Units (product number 101973-TAB) for the AngioJet Rheolytic Thrombectomy System (AngioJet System), Recall # Z-0714-2.

REASON: Loose hardware can fall on the circuit board producing an intermittent or permanent electrical failure of the Drive Unit.

MANUFACTURER: Medel Italiana Srl Polo di Torrile, Italy. Firm initiated recall is ongoing.

PRODUCT: Comp-Air Elite Rechargeable Battery and DC Auto Adapter for NE-C21 Comp-Air Elite Compressor, Model C21BATKIT; Made in Italy. Recall # Z-0715-2.

REASON: Premature failure of rechargeable battery.

MANUFACTURER: Merit Medical Systems, Inc., South Jordan, UT, by a Merit employee beginning November 1, 2001. Firm initiated recall is ongoing.

PRODUCT: 1) Merit Manifolds 2) Merit Coronary Control Syringes 3) Merit Fluid Administration Sets 4) Merit Custom Convenience Sets 5) Merit Contrast Management System 6) Merit Disposal Depot 7) Merit Pressure Monitoring Tubing 8) Merit VacLok Syringes.

Recall # Z-0716-2/Z-0723-2.

REASON: Seals on Tyvek/Nylon pouches are potentially defective.

MANUFACTURER: Baxter Healthcare Corporation Cleveland, MS. Firm initiated recall is ongoing.

PRODUCT: Baxter Spinal Anesthesia Trays, product code 1T2356. Recall # Z-0724-2.

REASON: Trays labeled with incorrect expiration date.

MANUFACTURER: Nichols Institute Diagnostics, San Juan Capistrano, CA, by letter dated January 25, 2002. Firm initiated recall is complete.

PRODUCT: Nichols Advantage Thyroglobulin Assay, An in-vitro diagnostic intended for the quantitative mesurement of Thyroblobulin in human serum. Recall # Z-0725-2.

REASON: Dilution result may read less than the 0.9 ng/mL negative out-off.

MANUFACTURER: Deroyal Orthopedic Fabrication, Maynardville, TN.

Firm initiated recall is ongoing.

PRODUCT: Premium Abduction Pillow with Kodel Band; Custom Abductor

Pillow; and 6” Patella Strap. Recall # Z-0726-2/0727-2.

REASON: Undeclared natural rubber.

MANUFACTURER: Sysmex Corporation Kobe, Japan. Firm initiated recall is ongoing.

PRODUCT: Sysmex Automated Hematology Analyzers and Sysmex Automated Reticulocyte Analyzers.

Recall # Z-0731-2/Z-0742-2.

Models:

a) K-4500, Automated Hematology Analyzer, an in-vitro device for use in clinical laboratories to analyze whole blood samples as a screening device for identifying samples with abnormal cells.

b) R-3500, Automated Reticulocyte Analyzer, a fully automated reticulocyte analyzer for in-vitro diagnostic use in clinical laboratories.

c) SF-3000, Automated Hematology Analyzer, an in-vitro device for blood cell analysis in clinical laboratories, as a screening device for identifying samples with abnormal cells. Medical Technologists are responsible for final review of abnormal cells.

d) SE-9000, Automated Hematology Analyzer, 23 parameters, an in-vitro device for whole blood cell analysis in clinical laboratories, as a screening device to flag specimens containing abnormal blood cells. Medical Technologists are responsible for final review of abnormal cells.

e) SE-9500, Automated Hematology Analyzer, 25 parameters, an in-vitro device for whole blood cell analysis in clinical laboratories, as a screening device to flag specimens containing abnormal blood cells. Medical Technologists are responsible for final review of abnormal cells.

f) SP-100, Automated Hematology Slide Preparation Unit.

g) XE-2100, Automated Hematology Analyzer, 32 parameters, networking capability, intended to classify formed elements in EDTA anti-coagulated blood.

h) XE-2100L, Automated Hematology Analyzer, 26 parameters, networking capability, expandable to the XE-2100L Twin System, intended to classify formed elements in EDTA anti-coagulated blood.

i) SE-Alpha, Integrated Hematology System, receives the data from the SE-9000/9500 automated hematology analyzer and directs the SP-100 to prepare a blood film and stain on appropriate samples, to perform complete hematology analysis, slide preparation and staining in a walk-away environment.

j) SE-HST, Total Hematology Automation System, receives the data from the SE-9000/9500 automated hematology analyzer and the R-3500 automated reticulocyte analyzer, and directs the SP-100 to prepare a blood film and stain on appropriate samples, utilizing the HST conveyor transport system which automates the manual transfer of blood sample racks between devices and to automate manual blood film preparation.

k) XE-Alpha, Hematology Alpha Transportation System, receives the data from the XE-2100 automated hematology analyzer and directs the SP-100 to prepare a blood film and stain on appropriate samples, to perform complete hematology analysis, slide preparation and staining in a walk-away environment.

l) XE-HST, Total Hematology Automation System, receives the data from the XE-2100 automated hematology analyzer and the R-3500 automated reticulocyte analyzer, and directs the SP-100 to prepare a blood film and stain on appropriate samples, utilizing the HST conveyor transport system which automates the manual transfer of blood sample racks between devices and to automate manual blood film preparation.

REASON: Potential misidentification of samples.

MANUFACTURER: TFX Medical Annacotty, Co., Liomerick, Firm initiated recall ongoing.

PRODUCT: Boston Scientific Medi-Tech Imager II 4 Fr Angiographic Catheters in the types and models described below:

Product Description Catalog Numbers

a) 4F/Tennis Racquet .035”/65 cm M001315001

b) 4F Tennis Racquet .035”/90 cm M001315011

c) 4F Pigtail .035”/65 cm M001315091

d) 4F Straight .035”/65 cm M001315101

e) 4F Pigtail .035”/90 cm M001315111

f) 4F Straight .035”/90 cm M001315121

g) 4F Contra .035”/65 cm M001315251

h) 4F Contra .035”/90 cm M001315261

i) 4F Contra .035”/100 cm M001315271

Recall # Z-0743-2/0751-2.

REASON: Catheter tip may separate from the device if significant flexing forces are applied.

MANUFACTURER: Genzyme Corp., Cambridge, MA. Firm initiated recall is ongoing.

PRODUCT: Becton Dickinson's ColorPAC brand Giardia/Cryptosporidium Rapid Assay in-vitro diagnostic kit, packaged in papercard box, each kit containing instructions, reagents and components to perform 30 tests. Recall # Z-0756-2.

REASON: IVD kit may exhibit false positive results.

MANUFACTURER: The Kendall Co. lp, Argyle, NY. Firm initiated recall is ongoing.

PRODUCT: Kendall Mahurkar 12Fr Triple Lumen Catheter Kits and Trays. Recall # B-0757-2/B-07561-2.

REASON: Dialysis catheter connection may crack and cause leakage of fluid.

MANUFACTURER: Specialty Surgical Products, Inc., Victor, MT, by telephone and fax on December 20, 2001. Firm initiated recall is complete.

PRODUCT: Mammary sizer; intraoperative determination for volume of breast implants. Recall # Z-0764-2/Z-0765-2.

REASON: Product mislabeled as sterile when it was non-sterile.

MANUFACTURER: Roche Diagnostics, Mannheim, Germany. Firm initiated recall is ongoing.

PRODUCT: Roche/Hitachi Tina-quant IgM. Recall # Z-0768-2.

REASON: Precipitate in r2 bottle causes false high or low results.

MANUFACTURER: Sysmex Corporation of America, Long Grove, IL, by "End

User Bulletin" on January 18 and March 19, 2002.

Firm initiated recall is ongoing.

PRODUCT: Sysmex Automated Hematology Analyzers.

Models:

a) XE-2100, Automated Hematology Analyzer, 32 parameters, networking capability, catalog #983-1341-1. Recall # Z-0774-2;

b) XE-2100L, Automated Hematology Analyzer, 26 parameters, networking capability, expandable to the XE-2100L Twin System, catalog #993-3731-9 (L). Recall # Z-0775-2.

REASON: Potential misidentification of samples due to a time out error.

MANUFACTURER: Sysmex Corporation of America, Long Grove, IL, by e-mail to Roche on January 18 and "End User Bulletin" on March 19, 2002. Firm initiated recall is ongoing.

PRODUCT: Sysmex Automated Hematology Analyzers.

Models:

a) XE-2100, Automated Hematology Analyzer, 32 parameters, networking capability, catalog #983-1341-1. Recall # Z-0776-2;

b) XE-2100L, Automated Hematology Analyzer, 26 parameters, networking capability, expandable to the XE-2100L Twin System, catalog #993-3731-9 (L).

Recall # Z-0777-2.

REASON: Potential misidentification of samples.

MANUFACTURER: Microsurgical Technology, Inc., Redmond, WA, by telephone on May 8 and letters on June 5, 2001. Firm initiated recall is complete.

PRODUCT: Aspiration tube of I/A stainless steel handpieces part number 10-030. I/A handpieces are used in cataract surgery to aspirate and irrigate the lens cavity. Recall # Z-0778-2/Z-0780-2.

REASON: Leaking aspiration tubes.

CLASS III

MANUFACTURER: Ortho-Clinical Diagnostics, INC. Rochester, NY, by telephone on July 5, 2001. Firm initiated recall complete.

PRODUCT: Vitros Digoxin Slides, for use with Vitros Chemistry Systems to quantitatively measure Digoxin concentration in serum and plasma.

Recall # Z-0025-2.

REASON: Analyzer could produce biased results due to incorrect lot # on barcode.

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN, by correction notice dated November 13, 2001. Firm initiated recall is ongoing.

PRODUCT: All DataCare Systems Software, as follows:

a) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9200

b) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9201

c) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog BP9251

d) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog BP9252

e) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog; GD9200

f) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9201

g) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog; GD9206

h) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog; GD9207

i) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog; GD9208

j) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog; BP9251

k) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog; BP9252

l) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9202

m) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9209

n) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9010

o) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9211

p) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9212

q) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog BP9215

r) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog BP9216.

Recall # Z-0682-2/Z-0699-2.

REASON: Potential patient/sample mismatch.

MANUFACTURER: Micro Motors, Inc. Santa Ana, CA, by telephone and letter on February 28, 2002. Firm initiated recall is ongoing.

PRODUCT: DynaTorq brand Dental Torque Wrench. Recall # Z-0752-2/Z-0754-2.

REASON: Error in torque setting.

MANUFACTURER: Hill-Rom Co. Inc., Batesville, IN, by letter on or about February 7, 2002. Firm initiated recall is complete.

PRODUCT: Hill-Rom Utility Shelf for placement of equipment on the Uniflex headwall. Model P105001. Recall #Z-0762-2.

REASON: Electrical shock hazard.

MANUFACTURER: Becton Dickinson Infusion Therapy Systems, Inc., Sandy, UT. Firm initiated recall is ongoing.

PRODUCT: Boston Scientific/Medi-Tech:

Vaxcel PICC Peripherally Inserted Central Catheter 6 Fr Dual Lumen Clampable Hub, 130 cm Wire Catalog Number: 45-426. Recall # Z-0763-2.

REASON: Outer Carton is mislabeled as 6 Fr Dual Lumen, inner label correctly identifies product as a 5 Fr Single Lumen.

MANUFACTURER: Microsurgical Technology, Inc., Redmond, WA, by telephone on April 25, 2001. Firm initiated recall is complete.

PRODUCT: Aspiration Slug in the Phaco handpieces - Phaco handpieces are AC-powered devices with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

Recall # Z-0766-2/0767-2.

REASON: Burr in aspirator pathway.

MANUFACTURER: Cook, Inc., Bloomington, IN, by letter dated November 27, 2001. Firm initiated recall is ongoing.

PRODUCT: a) Cook Check-Flo Plus Introducer Set, 12 French.

Recall # Z-0771-2;

b) Cook Check-Flo Plus Introducer Set, 14 French.

Recall # Z-0772-2;

c) Cook Check-Flo Plus Introducer Set, 16 French.

Recall # Z-0773-2.

REASON: Valve may move into patient through introducer.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of
April 03, 2002:

MANUFACTURER: Sunquest Information Systems, Inc., Tucson, AZ, by mailing June 21, 2001. Firm initiated recall is ongoing.

PRODUCT: FlexiLab Laboratory Information System, versions 5.23 and 5.3 with Specimen Management Routing and Tracking (SMART). Recall # Z-0656-2.

REASON: Container ID labels print incorrectly, names of patients mix.

MANUFACTURER: Matrix Technologies Corp., Hudson, NH, by letter dated December 20, 2001. Firm initiated recall is ongoing.

PRODUCT: ID-MTS (Micro Typing System) IMPACT Pipettor. Recall # Z-0667-2.
 

REASON: Motor may fail resulting in inaccurate volume filling and causing a false negative test result.

MANUFACTURER: Manufacturer: Becton Dickinson Microbiology Systems, Cockeysville, MD. Firm initiated recall is ongoing.

PRODUCT: Haemophilus Test Medium Agar, catalog #221954, packaged as plated media, 8 plates per plastic package. Recall # Z-0668-2.

REASON: Micobiological test media may exhibit insufficient growth of bacteria

MANUFACTURER: Beckman Coulter, Inc. Brea, CA, by letter dated February. 8, 2002. Firm initiated recall is a 24- hour alert.

PRODUCT: Beckman Coulter Synchron LX20 Clinical System. This is a machine used to perform clinical chemistry tests on patient specimens. Recall # Z-0670-2.

REASON: Synchron LX20 Low cc side chemistries.

MANUFACTURER: DM Medical, Inc. Cincinnati, OH, by recall notices on February 28, 2002. FDA initiated recall is ongoing.

PRODUCT: Smoke Evacuator Hoses, sterile and non-sterile, single use only. Recall # Z-0671-2/Z-0676-2.

Each hose unit is packaged in a Tyvek bag under the DM Medical label, with a disposable aspirator adapter. The following items are recalled:

Catalog # Description

HA-3 1 1/4" X 5' Sterile tubing,10/box.

Recall #Z-671-2;

HA-4 1 1/4" X 5' Non-Sterile tubing,10/box.

Recall #Z-0672-2;

HA-8 1 1/4" X 10' Sterile tubing, 5/box.

Recall # Z-0673-2;

HA-9 7/8" X 10' Sterile tubing, 10/box.

Recall # Z-0674-2;

HA-9N 7/8" X 10' Non-sterile tubing, 10/box.

Recall # Z-0675-2;

0007-1810 7/8" X 10' Sterile tubing, 10/box.

Recall # Z-0676-2.

REASON: QSR deviations including: no validated sterilization process, and lack of 510 (k).

CLASS III

MANUFACTURER: GenSci OrthoBiologics, Inc., Irvine, CA, by notice dated November 12, 2001. Firm initiated recall is complete.

PRODUCT: DynaGraft Gel and Putty, a mixture of human demineralized allograft bone powder mixed with a reverse-phase medium and formulated into a gel or putty consistency. Packed into 10 cc plastic syringes, 10 cc Nagalene vials or 1 cc Nagalene vials.

Recall # Z—0596-2.

REASON: Donor Screening Problems.

MANUFACTURER: Medi Tech a division of Boston Scientific, Salt Lake City, UT. Firm initiated recall is ongoing.

PRODUCT: PASV (Pressure Activated Safety Valve) PICC Peripherally Inserted Central Catheters.

Recall # Z-0657-2/0658-2.

REASON: Instructions for use and/or patient information guides may be omitted.

MANUFACTURER: Roche Diagnostics, Mannheim, Germany.

Firm initiated recall is ongoing.

PRODUCT: Roche CSA Cobas Integra 700 Cyclosporine reagent.

Recall # Z-0669-2.

REASON: Revised calibration frequency due to reduced standard curve stability.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of
March 27, 2002

CLASS I

MANUFACTURER: Manufacturer: Olympus Optical Co., Ltd., Shinjuku-ku, Tokyo, Japan. Firm initiated recall is ongoing.

PRODUCT: Brand name: Olympus Bronchoscope

15 Model Numbers: BF-40, BF-P40, BF-1T40, BF-3C40, BF-XP40, BF-XT40, BF-240, BF-P240, BF-1T240, BF-6C240, BF-160, BF-P160, BF-1T160, BF-3C160, BF-XT160. Common name: Video Bronchoscope Classification name: Bronchoscope (flexible or rigid). Recall # Z—573-2/Z-0587-2.

REASON: Loosened bronchoscope biopsy channel port & microbial contamination of the port.

MANUFACTURER: A & A Medical/Rocket USA, Alpharetta, GA, by letter on March 13, 2002. Firm initiated 24 hour alert.

PRODUCT: Various OB/GYN surgical devices labeled as sterile or processed by ETO. Recall # Z-0597-2.

REASON: GMP deficiencies.

CLASS I

MANUFACTURER: Edwards Lifesciences, LLC Anasco, Puerto Rico. Firm initiated recall is ongoing.

PRODUCT: Intro-Flex Percutaneous Introducer Kits with AMC Thromboshield an Antimicrobial Heparin Coating. Size 8.5 F (Model 1652BF85H) and 6F (Model 1500F6). Recall # Z-0588-02/Z-0589-02.

REASON: Product may have inadequate tray seal strength to ensure the sterility of the product for its stated life shelf.

MANUFACTURER: Becton Dickinson Diagnostic Systems, Sparks, MD, by urgent product recall notice on December 19, 2001. Firm initiated recall is ongoing.

PRODUCT: Becton Dickinson's Directigen(tm) Flu A+B in-vitro diagnostic test kit, packaged in papercard boxes, each box containing instructions, reagents and controls to perform 20 tests. Recall # Z-0590-2.

REASON: Directigen (tm) test kit for Influenza may give false positive result.

MANUFACTURER: ST. Jude Medical, Inc., Daig Div., Minnetonka, MN, by firm

representatives on February 7, 2002. Firm initiated

recall is ongoing.

PRODUCT: a) ANGIO-SEAL Vascular Closure Device 6F STS Platform, product re-order number 610110;

b) ANGIO-SEAL 6F Vascular Closure Device, product re-order number 610092. Recall # Z-0592-2.

REASON: There are missing drip and blood inlet holes from the arteriotomy locator of some of the devices.

MANUFACTURER: Bci, Inc., Waukesha, WI, by recall notice on February 21, 2002. Firm initiated recall is ongoing.

PRODUCT: BCI Handheld Pulse Oximeter, Catalog number 3303.

Recall # Z-0593-2.

REASON: Inappropriate restart of the device can occur in about 10% of the devices if the audio alarm is set to the highest volume. Restart is a 2 minute period without alarms.

MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by letter dated December 7, 2001. Firm initiated recall is ongoing.

PRODUCT: AEROSET System Software v1.00ER005.2 and v1.0ER005 Catalog Numbers: 2-8996-02 and 2-89996-01.

Recall # Z-0594-2/0595-2.

REASON: System may incorrectly associate sample ID & test requests under certain conditions of non-bar coded or unreadable bar coded samples.

MANUFACTURER: Badger Electronics, Franksville, WI. Firm initiated recall is ongoing.

PRODUCT: Battery pack for the Criticare Multiple Parameter Telemetry MPT 2.4, Catalog Number 944-C.

Recall # Z-0598-2.

REASON: Some of the battery packs overheat during use. The heat may melt the battery casing and device case.

MANUFACTURER: Survivalink Corp., Minneapolis, MN, by letter dated October 24, 2001. Firm initiated recall is ongoing.

PRODUCT: Survivalink FirstSave STAR Biphasic Automatic External

D efibrillators, Model Numbers 9200, 9210, 9200D, & 9210D. Recall # Z-0599-2/Z-0602-2.

REASON: Product could fail to deliver defribrillation shocks.

MANUFACTURER: HILL-ROM, Inc., Batesville, IN, by letter dated January 30, 2002. Firm initiated recall is ongoing.

PRODUCT: TotalCare treatment beds, as follows:

a) Hill-Rom brand TotalCare beds.

b) Hill-Rom brand TotalCare SpO2RT beds

Recall # Z-0627-2/0628-2.

REASON: Unintentional movement of bed or failure of controls to operate.

MANUFACTURER: Microgenics, Fremont, CA. Firm initiated recall is ongoing.

PRODUCT: Abbott Carbon Dioxide Calibrator, In-Vitro Diagnostic, Recall # Z-0635-2.

REASON: Results run low.

MANUFACTURER: Fisher Scientific, Middletown, VA. Firm initiated recall is ongoing.

PRODUCT: a) Bayer Immuno 1(R) System, Bayer(R) TESTpoint(TM) TROPONIN I CONTROLS. Recall # Z-0637-2;

b) Bayer Immuno 1(TM) System Bayer SETpoint(TM) TROPONIN I CALIBRATORS. Recall # Z-0638-2.

REASON: Degradation of products under current storage conditions.

MANUFACTURER: Haemonetics Corp., Braintree, MA, by letter on January 28, 2002. Firm initiated recall is ongoing.

PRODUCT: OrthoPAT Autotransfusion Set, Sterile Distributed by: Zimmer, Dover, OH. Recall # Z-0639-2.

REASON: Product's sterility maybe compromised as the sterilization dose was not adequate.

MANUFACTURER: Bayer Corporation, Business Group Diagnostics East Walpole, MA. Firm initiated recall is ongoing.

PRODUCT: Brand Name: Bayer ADVIA(R) Centaur(TM) Rubella IgG Assay

Common Name: A chemiluminescence test for determination of IgG antibodies to the Rubella virus (an in vitro diagnostic). Recall # Z-0640-2.

REASON: Use of assay for quantification of IgG antibodies may yield incorrect results.

MANUFACTURER: HILL-ROM, Inc., Batesville, IN, by letter dated February 20, 2002. Firm initiated recall is ongoing.

PRODUCT: Hill-Rom TotalCare SpO2RT pulmonary therapy bed system. Recall # Z-0642-2.

REASON: Siderails may stay up without latching into place.

MANUFACTURER: Chester Labs, Inc., Cincinnati, OH, by mail on January 11, 2002. Firm initiated recall is complete.

PRODUCT: Graham-Field brand Ultrasound Scanning Gel, packed in 1 gallon (128 oz.) plastic jugs, four (4) units per carton, packaged under the GRAHAM-FIELD private label. Recall # Z-0643-2.

REASON: Products distributed prior to complete manufacturing process validation. The lots failed microbial specifications.

MANUFACTURER: The Anspach Effort, Inc., Palm Beach Gardens, FL by letter on January 26, 2001. Firm initiated recall is ongoing.

PRODUCT: Anspach brand 2.15 X 22.0 mm Spiral Router.

Recall # Z-0644-2.

REASON: High speed cutters will not fit into the motor drill system.

MANUFACTURER: Ethicon LLP San Lorenzo, Puerto Rico. Firm initiated recall is ongoing.

PRODUCT: LIGACLIP Extra Ligating Clip Cartridge, implantable, sterile, single patient use. Each cartridge contains 6 titanium ligating clips, individually packaged in a copolyester blister and heat-sealed with a Tyvek lid/pouch. Each sales unit/carton contains 36 cartridges. Size: Medium. Recall # Z-0650-2

REASON: Sterility of the device may be compromised as evidenced by a loss of package integrity.

MANUFACTURER: Sangstat Medical Corporation Fremont, CA, by telephone on February 8, 2002. Firm initiated recall is ongoing.

PRODUCT: SangStat brand Celsior™ Cold Storage Solution.

Recall # Z-0651-2.

REASON: Product is contaminated with unknown black residue.

MANUFACTURER: Arrow Internacional de Mexico, S.A. DE C.V. COL.

Panamericana, Chihuahua. Firm initiated recall is ongoing.

PRODUCT: Arrow Spring Wire Guide 0.025" x 23 5/8". The catalog number is AW-14725. Recall # Z-0653-2.

REASON: Mislabeled 0.025 when it is actually 0.035 diameter.

CLASS III

MANUFACTURER: Siemens AG Medical Solutions, Forchheim, Germany. Firm initiated recall is ongoing.

PRODUCT: Leonardo Workstation, Image processing system, Diagnostic imaging. Recall # Z-0439-2.

REASON: Partial X-Ray images being transmitted to other receiving workstations.

MANUFACTURER: Minntech Corp., Minneapolis, MN, by letter dated November 13, 2001. Firm initiated recall is ongoing.

PRODUCT: Renasol Liquid Bicarbonate Concentrate BC-1-L Part B in one gallon (3.78 liter) bottles. Centrasol Liquid Bicarbonate Concentrate MB-330-L Part B in one gallon (3.78 liter) bottles. Recall # Z-0591-2.

REASON: Aureobasidium pullulans, a yeast that can form chains as a fungus, is in the recalled products.

MANUFACTURER: Siemens AG Medical Engineering, Forcheim, Germany. Firm initiated recall is complete.

PRODUCT: a) ACOM.PC Angiographic X-ray System;

b) Digital Image Communications System.

Recall # Z-0603-2.

REASON: Software problem in recording heights and weights.

MANUFACTURER: Minntech Corporation, Minneapolis, MN, by telephone beginning January 21, 2002. Firm initiated recall is ongoing.

PRODUCT: Renatron II, Renatron PA, and Renatron 100 Dialyzer Reprocessing System machines, and the Renaclear Dialyzer Cleaning system. Recall # Z-0629-2/0631-2.

REASON: The recalled devices have internal stainless steel valve components that may corrode.

MANUFACTURER: Abbott Laboratories, Inc., Abbott Park, IL, by letter dated January 11, 2002. Firm initiated recall is complete.

PRODUCT: Abbott AxSYM System Solution 4 Line Diluent; 10 L cubitainers (bag in box); item no. 8A46-01; for in vitro diagnostic use; 0.1 M Phosphate Buffer with sodium azide preservative and antimicrobial agent; Abbott Laboratories, Abbott Park, IL. Recall # Z-0632-2.

REASON: Line Diluent causes opiate assay controls out of range high.

MANUFACTURER: Abbott Laboratories, Inc., Abbott Park, IL, by letter dated January 16, 2002. Firm initiated recall is ongoing.

PRODUCT: Architect Prolactin Calibrators, list number 6C27-01; 2 - 4 mL bottles of calibrators per box; Abbott Laboratories, Diagnostics Division, Abbott Park, IL. Recall # Z-0633-2.

REASON: Calibration failures.

MANUFACTURER: Bayer Corporation, Mishawaka, IN. Firm initiated recall is ongoing.

PRODUCT: Clinitek 100 Software Kit. Recall # Z-0634-2.

REASON: False negative results when high concentrations of ketone exist.

MANUFACTURER: Diagnostic Products Corp., Los Angeles, CA, by letter dated December 10, 2001. Firm initiated recall is ongoing.

PRODUCT: Immulite Thyroid Autoantibody Control Module.

Recall # Z-0636-2.

REASON: Negative bias in control values.

MANUFACTURER: Instrumentation Laboratory Co., Orangeburg, NY. Firm initiated recall is complete.

PRODUCT: Brand Name: IL Test(TM) Cal 1 Solution Calibrator for use with IL Synthesis, 500 mL, for in vitro diagnostic use (only).(IL: Instrumentation Laboratory) Recall # Z-0641-2

REASON: Elevated electrolyte values with lot N0811766.

MANUFACTURER: ARDET s.r.l. 20090, Buccinasco, MI. Firm initiated recall is complete.

PRODUCT: DENT-X Image-X 70(R) Plus Intra-Oral X-Ray Imaging System,

Intraoral Diagnostic X-Ray Unit With X-Mind(R) Timer Control, Catalog/Model Number 9992700100. 510(k)# K000551. The Installation, Operation & Service Manual (Part Number 897-000001) is the affected component for this "Field Correction". Recall # Z-0645-2.

REASON: Incorrect wiring instructions - connection for the line and neutral terminals were reversed.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of
March 13, 2002

CLASS II

MANUFACTURER: Meridian Bioscience, Inc., Cincinnati, OH, by letters on Dec. 10, 2001. Firm initiated recall is ongoing.

PRODUCT: Premier Adenoclone Type 40/41, an EIA diagnostic test kit. Recall # Z-0556-2.

REASON: The kits may product false positive test results due to cross-reactivity.

MANUFACTURER: Greiner bio-one, Austria. Firm initiated recall is ongoing.

PRODUCT: Vacuette 3.5 ml Coagulation Tube (blue top tubes), Item # 454327. Recall # Z-0557-2.

REASON: Partially filed tubes, which can cause erroneous results.

MANUFACTURER: Ciba Vision Corp., Duluth, GA, by letter on Nov. 30, 2001. Firm initiated recall is ongoing.

PRODUCT: Torisoft Daily Wear Soft Contact Lens.

Recall # Z-0558-2.

REASON: Experimental design tool was used to manufacture product.

MANUFACTURER: St. Jude Medical ATG, Inc., St. Jude Medical, Inc., Maple Grove, MN, by visit on December 18, 2001. Firm initiated recall is ongoing.

PRODUCT: Symmetry Bypass System Aortic Connector, Model Number ACN-5055. Recall # Z-0559-2.

REASON: The wrong sized vein transfer sheath was included in the product packages.

MANUFACTURER: Parallax Medical, Inc., Scotts Valley, CA, by fax and telephone on January 10, 2002 and by letters on January 11, 2002. Firm initiated recall is ongoing.

PRODUCT: Parallax brand EZflow Cement Delivery System.

Recall # Z-0560-2.

REASON: The cannula may break when subjected to high torsional load.

MANUFACTURER: Beckman Coulter Inc., Miami, FL. Firm initiated recall is ongoing.

PRODUCT: Coulter GEN S (tm) Hematology Analyzers.

Recall # Z-0561-0563-2.

REASON: Erroneous low results as an artifact of dilution of blood sample at aspiration.

MANUFACTURER: bioMerieux, Inc., Durham, NC, by letter on December 19, 2001. Firm initiated recall is ongoing.

PRODUCT: Simplastin HTF, Recall # Z-0564-2.

REASON: Increased frequency of inconsistent & possibly incorrect clot times.

MANUFACTURER: Portex, Inc., Keene, NH, by letter on January 22, 2002. Firm initiated recall is ongoing.

PRODUCT: Portex Inner Cannula for the Blue Line Tracheal Tube.

Recall # Z-0565-2.

REASON: Sterility of the device may be compromised due to loss of package seal integrity.

MANUFACTURER: Nellcor Puritan Bennett, Inc., Minneapolis, MN, by telephone beginning January 11, 2002. Firm initiated recall is complete.

PRODUCT: Nellcor Puritan Bennett LP Power Motor Board Kits, Model L-1687 for LP Series (LP6 and LP10) Ventilators. Recall # Z-0568-2.

REASON: Power Motor Board failure could lead to ventilator failure.

MANUFACTURER: LEmaitre Vascular, Inc., Burlington, MA, by letter on December 7, 2001. Firm initiated recall is ongoing.

PRODUCT: a) LeMaitre Vascular VascuTape Glow'n Tell Tape, Sterile Product. Recall # Z-0569-2;

b) LeMaitre Vascular VascuTape Stent Guide.

Recall # Z-0570-2.

REASON: Sterility of the device may be compromised due to a loss of seal integrity.

MANUFACTURER: Centocor Diagnostics of PA, Inc. Firm initiated recall is ongoing.

PRODUCT: PSA Reagent Pack

For in vitro diagnostic use only, 100 test units per pack. Distributed by: Ortho-Clinical Diagnostics, Amersham, UK. Recall # Z-0571-

REASON: Product labeled for use outside U.S. shipped to domestic customers.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of
March 6, 2002

CLASS II

MANUFACTURER: Sunquest Information Systems Inc., Tucson, AZ, by mail on November 26, 2001. Firm initiated recall is ongoing.

PRODUCT: FlexiLab Laboratory Information System, Version 5.2, 5.23, and 5.3, Recall # Z-0531-02.

REASON: Software glitch can cause results to be filed under an incorrect accession number under certain conditions.

MANUFACTURER: Michigan Instruments Inc., Grand Rapids, MI, by field correction beginning in October 2000. Firm initiated recall is complete.

PRODUCT: Thumper Cardiopulmonary Resuscitator. Model 1007; catalog # 14000 and 15000, Recall # Z-0532-2.

REASON: Compressions may vary from 5:1 compression-ventilation ratio.

MANUFACTURER: Nellcor, Div. of Tyco Healthcare Group LP, Tijuana, MX. Firm initiated recall is ongoing.

PRODUCT: Valleylab CUSA EXcel Manifold Tubing 36kHz, Sterile, Made in Mexico. Packaged 6 per case. Recall # Z-0533-2.

REASON: Sterilization can not be assured for entire lot.

MANUFACTURER: Deroyal Surgical, Rose Hill, VA, by mail on December 10, 2001. Firm initiated recall is ongoing.

PRODUCT: Surgimate (tm) brand, Sterile Instrument Pouches, aka "surgical drapes", packed in surgical grade white paper pouches, 100 pouches per case. Pouches are labeled with item #31-283, sterility exp. date "2006-11". Recall # Z-0534-2.

REASON: Surgical drapes labeled as sterile may contain non-sterile product.

MANUFACTURER: Closure Medical Corp., Raleigh, NC, by letter dated November 27, 2001. Firm initiated recall is ongoing.

PRODUCT: Dermabond Topical Skin Adhesive, Model No. BD12.

Recall # Z-0535-2.

REASON: Inadequate seal in the blister packaging.

MANUFACTURER: Encision Inc., Boulder, CO, by phone or visit beginning October 25, 2001. Firm initiated recall is ongoing.

PRODUCT: 35cm J-Hook Electrode. Recall # Z-0536-2.

REASON: J-hook, fixed-tip electrode may break off during electrosurgical use.

MANUFACTURER: Cas Medical Systems Inc., Branford, CT, by letter on December 17, 2001. Firm initiated recall is ongoing.

PRODUCT: Infant Apnea Monitors as follows:

a) AMI 9700 Apnea Monitor, Recall # Z-0537-2;

b) AMI 9700A Apnea Monitor, Recall # Z-0538-2;

c) AMI Plus 9700B Infant Central Apnea/Heart Rate Monitor,

Recall # Z-0539-2.

REASON: Infant Apnea Monitor may shut down and the audible alarm may fail to sound.

MANUFACTURER: Chase Medical Inc., Athens, TX, by letter dated November 28, 2001. Firm initiated recall is ongoing.

PRODUCT: Dual Stage Venous Return Cannula with Bullet Tip intended for use as a single tube venous drainage from the right atrium and vena cava during extracorporeal circulation for open-heart surgery. The product is labeled in part: "Dual Stage Venous Return Cannulae Chase Medical, Inc., Richardson, TX", packaged individually, sterile and 10 to a case. Recall # Z-0540-2/0545-2.

REASON: Venous Return Cannula Tip may separate in use

MANUFACTURER: Guidant Corp., Temecula, CA, by letter beginning Dec. 22, 2001. Firm initiated recall is ongoing

PRODUCT: Rx Multi Link Penta Coronary Stent Systems, U.S. and

Rx Multi Link Penta Coronary Stent Systems, CE. Common

Name for this device is Rapid Exchange Coronary Stent

System. Classification Name is Coronary Stent.

Recall # Z-0546-2.

REASON: Potential compromise of sterility.

MANUFACTURER: Hypoguard (USA) Inc., formerly Chronimed Inc. Edina, MN, by letters on Jan. 4, 2002. Firm initiated recall is ongoing.

PRODUCT: Supreme Blood Glucose Test Strips, Product Number 880050, 50-count bottles and Select GT Blood Glucose Test Strips, Product Number 660100, 100-count (a carton containing two 50-count bottles).

Recall # Z-0547-2.

REASON: The product gives abnormally low readings when samples have high glucose levels.

MANUFACTURER: Baxter Healthcare Corp., Singapore, SN. Firm initiated recall is ongoing.

PRODUCT: Colleague Infusion Pumps:

a) Colleague Single Channel Volumetric Infusion Pumps,

Recall # Z-0548-2;

b) Colleague 3 Triple Channel Volumetric Infusion Pumps,

Recall # Z-0549-2.

REASON: Malfunction of on/off circuit.

MANUFACTURER: Medtronic Sofamor Danek Manufacturing, Warsaw, IN, by letters dated Oct. 19, 2001. Firm initiated recall is complete.

PRODUCT: CD HORIZON Spinal System Laminar Hook. REF/Catalog # 84101H. Non-sterile. The product is distributed in individual packages. Recall # Z-0550-2.

REASON: Reduced tensile strength.

MANUFACTURER: Medikmark Inc., Waukegan, IL, by letters on August 16, 17 and 20, 2001. Firm initiated recall ongoing.

PRODUCT: Sterile upper extremity drape surgical kits containing an "S" hook component, The "S" hook is used to attach the rope to the Stockinette to hold the arm in position for the surgery. Recall # Z-0553-2/0555-2.

REASON: S-hook may fail during use in surgery.

CLASS III

MANUFACTURER: New Deantronics Taiwan LTD., Hsin Tien City, by letter on October 30, 2001. Firm initiated recall is ongoing.

PRODUCT: Monopolar Foot Control Electrosurgical Pencils, as follows:

a) Foot Switch Pencil with Standard Electrode, single use, sterile. Catalog # PEN05. Recall # Z-0529-2;

b) Foot Switch Pencil with Coated Electrode, single use, non-sterile. Catalog # CK205. Recall # Z-0530-2.

REASON: Terminal may pull out of pencil body while the blade is being changed.

MANUFACTURER: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing.

PRODUCT: Magnetom Harmony, Symphony, Sonata, and Allegra Nuclear Resonance Magnetic Imaging System, Diagnostic Imaging.

Magnetom Harmony, Magnetom Symphony, Magnetom Sonata and Magnetom Allegra Nuclear Resonance Magnetic Imaging Systems, Diagnostic Imaging. Brand Label: "SIEMENS MAGNETOM Harmony MAGNETOM Symphony*** Whole Body Magnetic Resonance System*** Siemens Aktiengesellschaft*** Medical Engineering Group*** Henkestrasse 127, D-91052 Erlangen*** Order No. A91001-M2235-G800-2-7600"

"SIEMENS MAGNETOM*** Harmony Perfect your performance*** Siemens Aktiengesellschaft, Medical Engineering Group, Henkestrasse 127, D-91052 Erlangen*** aOrder No. A91100-M2220-E866-1-7600"

"SIEMENS MAGNETOM Symphony Master excellence in MR*** Siemens Aktiengesellschaft, Medical Engineering Group, Henkestrasse 127, D-9105 Erlangen*** Order No. A91100-M2220-E927-1-7600"

"SIEMENS MAGNETOM Sonata*** The Dedicated Cardiovascular MR System*** Siemens Aktiengesellschaft, Medical Engineering Group, Henkestrasse 127, D-91052 Erlangen*** Order No. A91004-M2220-E850-1-4A00"

"SIEMENS Preliminary Data Sheet*** MAGNETOM Allegra*** 3 Tesla Dedicated MR System*** version 4.5*** August 29, 2001". Recall # Z-0552-2.

REASON: Image reconstruction errors.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 20, 2002:

CLASS II

MANUFACTURER: GE Medical Systems, Information Technologies Milwaukee, WI, by letter dated July 20, 2001.

PRODUCT: Solar 9500 Physiological ECG monitor,
Recall # Z-0429-2.

REASON: The installation of incorrect chips could result in device failure.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 13, 2002:

CLASS I

MANUFACTURER: GE Medical Systems, Information Technologies Milwaukee, WI, by letter dated July 20, 2001. Firm initiated recall is complete.

PRODUCT: Solar 9500 Physiological ECG monitor,
Recall # Z-0429-02.

REASON: The installation of incorrect chips could result in device failure.

CLASS II

MANUFACTURER: Ortho-Clinical Diagnostics, Inc., Rochester, NY, by letters on Feb. 28, 2000. Firm initiated recall is complete.

PRODUCT: Vitros 950 and 950AT Chemistry Systems.
Responsible firm on the label: Made in U.S.A. Ortho-Clinical Diagnostics, a Johnson & Johnson Company, Rochester, NY 14626
Recall # Z-0073/0075.

REASON: Positive outliers for Potassium.

MANUFACTURER: Ortho-Clinical Diagnostics, Inc. Rochester, NY, by letters dated 4/8/1998, 2/2/1999 and 5/7/1999. Firm initiated recall ongoing.

PRODUCT: Vitros ECi Immunodiagnostic System.
Recall # Z-0165-01.

REASON: Biased results due to inadequate delivery of reagent fluids to the reaction well.

MANUFACTURER: Acumed, Inc., Beaverton, OR, by fax or E-mail on Nov. 9, 2001.

PRODUCT: Polarus Broach. Instrument belongs to the Polarus Humeral Rod System product line, which is a system of rods and screws for the fixation of humeral fractures and their accompanying instrumentation. The broach is reusable and provided non-sterile. Recall # Z-0501-02.

REASON: The word "lateral" is marked on the medial side of the broach.

MANUFACTURER: Datascope Corp., Cardiac Assist Division Fairfield, NJ, by letter on Nov. 19, 2001. Firm initiated recall is ongoing.

PRODUCT: Datascope's Profile 8 French Intra-Aortic Balloon Catheter. Recall # Z-0518/Z-0519-02.

REASON: Catheters may have a misalignment in the inner lumen path.

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN, by letters dated Jan. 9, 2002. Firm initiated recall is ongoing.

PRODUCT: Accu-Chek HQ System, Meter Cradle with Scanner. Recall #Z-0522-02/Z-0523-02.

REASON: Patient/sample mismatch.

MANUFACTURER: ADAC Laboratories, Milpitas, CA, by letters on Sept. 26, 2000. Firm initiated recall is complete.

PRODUCT: ADAC brand Pinnacle Radiation Therapy Planning System
Radiation Therapy Treatment Software version 5.2g, Recall # Z-0524-02.

REASON: A Software problem that could result in incorrect radiation dosage being applied.

MANUFACTURER: Ortho-Clinical Diagnostics, Inc. Rochester, by, by letter dated Dec. 26, 2001. Firm initiated recall is ongoing.

PRODUCT: Troponin I Reagent Pack - for In Vitro Diagnostic Use Only Cat 194 9882, 100 Test Units Responsible firm on the label: Ortho-Clinical Diagnostics, Amersham, UK. Recall # Z-0525-02.

REASON: False positive results on some serum & EDTA plasma samples.

MANUFACTURER: Cryolife, Inc. Kennesaw, GA, by letter on Dec. 12, 2001. Firm initiated recall is complete.

PRODUCT: CryoValve Allograft, Recall # Z-0528-02.

REASON: Donor kidney was positive for cancer.

CLASS III

MANUFACTURER: TriContinent Grass Valley, CA. Firm initiated recall is ongoing.

PRODUCT: Digene brand, Hybrid Capture (tm) System Automated Plate Washer I, Recall # Z-0526-02.

REASON: IVD microwell plate washer malfunctioned.

MANUFACTURER: M-Pact Corporation Eudora, KS. Firm initiated recall is ongoing.

PRODUCT: Soft Cell (tm), PVA Foam Surgical Spears, Quantity: 10 Spears per package, 150 Spears per case/carton,
Recall # Z-0527-02.

REASON: Increase in reports of kerratitis attributed to PVA Foam Spears from lot 1220C.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 6, 2002:

CLASS II

MANUFACTURER: Fujirebio Diagnostics Inc., Malvern, PA. Firm initiated recall is ongoing.

PRODUCT: Vitros Immunodiagnostics Products - PSA Reagent
Pack100 Test Units. Responsible firm on the label:
"Manufactured by: Centocor, Diagnostics of PA, Inc.
USA, Distributed by Ortho-Clinical Diagnostics,
Amersham, United Kingdom. Recall # Z-0451-02.

REASON: Positive bias on patient samples.

MANUFACTURER: St. Jude Medical ATG Inc., Maple Grove, MN, by retrieving the product beginning Oct. 6, 2001. Firm initiated recall is complete.

PRODUCT: Symmetry Aortic Connector System, Model Numbers CAN-550, Recall # Z-0508-02.

REASON: The tubeset was not securely held within the handle of the delivery system on some units.

MANUFACTURER: Zimmer Inc., Warsaw, IN, by letter dated Oct. 30, 2001. Firm initiated recall is ongoing.

PRODUCT: M/DN Intramedullary Fixation Humeral Nail. Catalog # 00-2254-255-10, Recall # Z-0510-02.

REASON: Proximal angled hole is oriented in the wrong direction and does not line up when a drill guide is used.

MANUFACTURER: Howmedica Osteonics Corp., Rutherford, NJ, by letter on Sept. 18, 2001 and by E-mail on Aug. 1, 2001. Firm initiated recall is ongoing.

PRODUCT: Duracon Total Knee Posterior Stabilizer (PS) Tibial Insert with Locking Screw, Recall # Z-0511-02.

REASON: The polyethylene post of the Duracon PS Tibial Inserts reportedly fracturing.

MANUFACTURER: Lifescan Inc., Milpitas, CA, by letter on Jan. 2, 2001. Firm initiated recall is ongoing.

PRODUCT: LifeScan brand One Touch Profile Meter, Blood Glucose Meter, Recall # Z-0513-02.

REASON: Some One Touch Profile Meters may develop display problems.

MANUFACTURER: Cordis Webster Inc., Baldwin Park, CA, by letter on Nov. 21, 2001. Firm initiated recall is ongoing.

PRODUCT: Preface Guiding Sheath, Recall # Z-0514-02.

REASON: Unacceptable tip wall thickness variation.

MANUFACTURER: Zeus Scientific Inc., Branchburg, NJ., by letter on April, 1999. Firm initiated recall is ongoing.

PRODUCT: Toxoplasma IgM Elisa diagnostic kit, Product No.508-A1 (Lots 128H6484, 108H6339), Product No. 508B (Lots #128H6485, 019H6449) Recall # Z-0515-02.

REASON: False positives; the positive standard has degraded.

MANUFACTURER: Howmedica Osteonics Corp., Rutherford, NJ, by fax on July 5, 2001. Firm initiated recall is complete.

PRODUCT: Guide Wires and Guide Pins (Class I devices, no 510k)
Recall # Z-0516-02.

REASON: Possible loss of sterile seal integrity.

MANUFACTURER: Roche Diagnostics Corp., Roswell, GA.
Firm initiated recall is ongoing.

PRODUCT: All DataCare Systems Software, as follows:

A) DataCare Server/Workstation Computer for DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9200. Sold in the U.S.

B) DataCare Networked Client Computer for DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9201. Dist. in U.S.

C) DataCare Server/Workstation Kit for customer that includes manual and software (sent in conjunction with DataCare Server/Workstation Computer for DataCare ABG Data Management System for use in a blood gas point of care testing environment); Catalog BP9251;

D) DataCare Networked Client Kit for customer that includes manual and software (sent in conjunction with DataCare Networked Client Computer for DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog BP9252;

E) DataCare Server/Workstation Computer for DataCare POC Software Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9200. Dist. in U.S., Canada and the United Kingdom;

F) DataCare Networked Client Computer for DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9201. Dist. in U.S., Canada and the United Kingdom;

G) DataCare Networked Client Computer for DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9206. Dist. U.S., Canada and the United Kingdom;

H) DataCare Power Class Server Computer for DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9207. Dist. U.S., Canada and the United Kingdom;

I) DataCare Laptop Computer for DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9208. Dist. U.S., Canada and the United Kingdom;

J) DataCare Server/Workstation Kit for customer that includes manual and software (sent in conjunction with DataCare Server/Workstation Computer for DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog BP9251. Dist. U.S., Canada and the United Kingdom;

K) DataCare Networked Client Kit for customer that includes manual and software (sent in conjuction with DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog BP9252. Dist. U.S., Canada and the United Kingdom;

L) DataCare Server/Workstation Computer for DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9202. Dist. U.S.;

M) DataCare Networked Client Computer for DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9209. Dist.U.S.;

N) DataCare Server Class Computer for DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9210. Dist. U.S.;

O) DataCare Power Class Server Computer for DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9211. Dist. U.S.;

P) DataCare Laptop Computer for DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9212. Dist. U.S.;

Q) DataCare Server/Workstation Kit for customer that includes manual and software (sent in conjunction with DataCare Server/Workstation Computer for DataCare GM Data Management System for use in a glucose only point of care testing environment); Catalog BP9215. Dist. U.S.;

R) DataCare Networked Client Kit for customer that includes manual and software for use in conjunction with DataCare Networked Client Computer for DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog BP9216; Dist. U.S.

Recall # Z-0517-02.

REASON: Possible sample results mismatch with patient information.

CLASS III

MANUFACTURER: Medtronic Inc., Minneapolis, MN, by letter beginning Sept. 6, 2001. Firm initiated recall is complete.

PRODUCT: LocaLisa IntraCardiac Navigation System, Model Numbers 9670000, 9670025, Recall # Z-0506-02.

REASON: A read only CD drive was installed in the system in place of a read-write CD drive.

MANUFACTURER: Konica Corp. Shinjuku-ku, Tokyo. Firm initiated recall is ongoing.

PRODUCT: Mammography Film, New CM-H Size 18 x 24 Emulsion Series 6107, Recall # Z-0512-02.

REASON: Mammography film does not meet speed or sensitivity control limits.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 30, 2002:

CLASS II

MANUFACTURER: Dade Behring, Inc. Brookfield, CT. Firm initiated recall is complete.

PRODUCT: Dimension Clinical Chemical Analyzer XL/RxL/ARx with software revision 5.2, Recall # Z-0433-02.

REASON: Instructions to software revision are missing a step.

MANUFACTURER: Ballard Medical Products, Pocatello, ID. Firm initiated recall is ongoing.

PRODUCT: Ballard Cytology Brush Disposable Cat. No. 60311, 1.8mm x 120 cm catheter, 2.0 mm bristle diameter, Recall # Z-0490-02; Cat. No. 60312, 1.8mm x 120 cm catheter, 3.0 mm bristle diameter, Recall # Z-0491-02; Cat. No. 60313, 1.8mm x 160 cm catheter, 2.0 mm bristle diameter, Recall # Z-0492-02; Cat. No. 60314, 1.8mm x 160 cm catheter, 3.0 mm bristle diameter, Recall # Z-0493-02.

REASON: Radiopaque distal tip may detach from the cytology brush.

MANUFACTURER: Institut Strauman AG Waldenburg, Switzerland. Firm initiated recall is ongoing.

PRODUCT: ITI Dental Implant System Handpiece Adapters. Recall # Z-0494-02/Z-0495-02.

REASON: Dental Handpiece Adapter fails specification and may remain lodged in the unit.

MANUFACTURER: ADAC Laboratories Milpitas, CA, by visit on Nov. 1, 2000. Firm initiated recall is complete.

PRODUCT: ADAC brand Forte Gamma Camera System, an Scintillation Gamma Camera, Tomography, Computed Emission, Recall # Z-0496-02.

REASON: Collimator drawer could drop to the floor causing injury to the user/patient.

MANUFACTURER: Fresenius HemoCare GmbH, The Netherlands. Firm initiated recall is ongoing.

PRODUCT: Therapeutic Plasma Exchange Set, Recall # Z-0497-02.

REASON: Return line of tubing set smaller than normal.

MANUFACTURER: Alatech Healthcare, LLC Slocomb, AL, by certified mail on Dec. 11, 2001. Firm initiated recall is ongoing.

PRODUCT: Lubricated latex condoms, model number 9030. Recall # Z-0498-02.

REASON: Failed FDA leak testing.

MANUFACTURER: Organogenesis Inc. Canton, MA, by telephone beginning on Dec. 7 and by fax on Dec. 10, 2001. Firm initiated recall is ongoing.

PRODUCT: Apligraf(Graftskin), Recall # Z-0499-02.

REASON: Product is contaminated with staphlococcus cohnii.

MANUFACTURER: Adac Laboratories Milpitas, CA, by visit in March 2000. Firm initiated recall is complete.

PRODUCT: ADAC brand Forte Gamma Camera System. An Scintillation Gamma Camera, Tomography, Computed Emission, Recall # Z-0500-02.

REASON: A sensor may not activate if proper contact is not made.

MANUFACTURER: Acumed, Inc., Beaverton, OR, by fax or E-mail on Nov. 9, 2001. Firm initiated recall is ongoing.

PRODUCT: Polarus Broach. Instrument belongs to the Polarus Humeral Rod System product line, which is a system of rods and screws for the fixation of humeral fractures and their accompanying instrumentation. The broach is reusable and provided non-sterile, Recall #Z-0501-02.

REASON: The word "lateral" was etched on the medial side of the broach.

MANUFACTURER: Abbott Laboratories, Inc. Abbott Park, IL, by letter dated Nov. 12, 2001. Firm initiated recall is ongoing.

PRODUCT: AxSYM Troponin-I Calibrators, list 3C29-01;6 bottles of calibrators A-F; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064, Recall # Z-0502-02.

REASON: Incorrect High Control readout due to stability failures of the calibrators.

MANUFACTURER: Ecolab Inc. Huntington, IN, by letter to the distributor in November, 2001. Firm initiated recall is ongoing.

PRODUCT: MediVators brand Rapicide High-Level Disinfectant and Sterilant. Active ingredient: Glutaldehyde. Recall # Z-0505-02.

REASON: Leaking bottles.

MANUFACTURER: ST. Jude Medical ATG, Inc., Maple Grove, MN, by visit on Oct. 6, 2001. Firm initiated recall is complete.

PRODUCT: Symmetry Aortic Connector System, Model Numbers CAN-4550, Recall # Z-0508-02.

REASON: The tubeset was not securely held within the handle of the delivery system on some units.

CLASS III

MANUFACTURER: Diagnostic Products Corp. Los Angeles, CA, by telephone and fax on Oct. 31, 2001. Firm initiated recall is ongoing.

PRODUCT: Immulite Cat Specific IgE; radioallergosorbent immunological test system. 100 test kit, Id# LKE11 115, Recall # Z-0437-02.

REASON: Packaging equipment failure, missing bead component.

MANUFACTURER: Abbott Health Products, Inc. Barceloneta, Puerto Rico, by letters on 11/8/01. Firm initiated recall is ongoing.

PRODUCT: AxSYM REA Ethanol Reagent. Distributed under the following brand: AxSYM Abbott Laboratories USA North, Recall # Z-0503-02.

REASON: Failure/inability to obtain a valid calibration curve

MANUFACTURER: Roche Diagnostics, Mannheim, Germany. Firm initiated recall is complete.

PRODUCT: Roche Glucl Cobas Integra Glucose HK Liquid, catalog # 2055651, Recall # Z-0504-02.

REASON: Reduced linearity/does not meet linearity range in directions for use.

MANUFACTURER: Medtronic, Inc. Minneapolis, MN, by letter on Sept. 6, 2001. Firm initiated recall is complete.

PRODUCT: LocaLisa IntraCardiac Navigation System, Model Numbers 9670000, 9670025, Recall # Z-0506-02.

REASON: A read only CD drive was installed in the system in place of a read-write CD drive.

MANUFACTURER: Scott Medical Products, Plumsteadville, PA, by telephone and letter dated Sept. 28, 2001. Firm initiated recall is ongoing.

PRODUCT: MedGraphics Pulmonary Function Gas, Reference Gas, 21% O2, Bal N2, Recall # Z-0507-02.

REASON: Concentration of oxygen is less than value stated on label.

MANUFACTURER: Amresco, Inc. Solon, OH, by fax on May 15, 2001. Firm initiated recall is complete.

PRODUCT: Pepsin 1:3000 NF XII Powder, packaged 500g in plastic bottles, 27mg in 2ml plastic vials, and 6,000g bulk bags inside plastic pails, Recall # Z-0509-02.

REASON: The product is contaminated with Salmonella bacteria.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 23, 2002:

CLASS II

MANUFACTURER: Johnson & Johnson Medical, Div. of Ethicon, Inc. Sherman, TX. Firm initiated recall is ongoing.

PRODUCT: 1) a non-prescription gauze, labeled in part: "NU GAUZE General- Use Sponges 2 in. x 2 in. - 4ply 2 SPONGES STERILE REORDER 2338 Johnson & Johnson Medical Division of Ethicon, Inc. Arlington, TX".

2) a non-prescription gauze, labeled in part: "MIRASORB Sponges 2 in. x 2 in. - 4ply 2 SPONGES STERILE REORDER 602318 Johnson & Johnson Medical Division of Ethicon, Inc. Arlington, TX". Both products are packaged 1500 to a case. Recall # Z-0334-02/Z-0335-02.

REASON: Seal Integrity - possibly non-sterile device.

MANUFACTURER: Hill-Rom Company, Batesville, IN, by letter dated Oct. 26, 2001. Firm initiated recall is ongoing.

PRODUCT: Hill-Rom Advanta 1600 series retractable med-surg beds with the optional accessory outlet. Recall # Z-0336-02.

REASON: Optional accessory outlet cable not secured properly and may be damaged with use and cause fire.

MANUFACTURER: Abiomed, Inc., Danvers, MA, by fax on Oct. 10, 2001. Firm initiated recall is complete.

PRODUCT: Abiomed BVS 5000t Bi-Ventricular Support System Transport/Backup Console. Recall # Z-0440-02.

REASON: Console's audible alarm may fail to signal.

MANUFACTURER: Cordis Europa Roden, Netherlands. Firm initiated recall is ongoing.

PRODUCT: Cordis Nylex 5F Flush Angiographic Catheters (Product Number 526510) and Cordis Tempo 4F Selective Diagnostic Catheters (Product Numbers 4514**VO), Recall # Z-0442-02/0443-02.

REASON: Increased tip stiffness with a potential for vessel damage

MANUFACTURER: Civco Kalona, IA., Firm initiated recall is complete.

PRODUCT: 6.5EC10 Disposable Biopsy Guide, P/N 5269613, Recall # Z-0445-02.

REASON: Disposable biopsy guide does not fit properly on the transducer and may shift.

MANUFACTURER: Instrumentation Laboratory Co. Orangeburg, NY. Firm initiated recall is ongoing.

PRODUCT: Hemoliance Brain Thromboplastin (HBT), 12 mL: Prothrombin Time Test. Recall # Z-0449-02.

REASON: International Sensitivity Index (ISI) incorrectly assigned for Prothrombin Time.

MANUFACTURER: Arjo Limited Gloucester, United Kingdom. Firm initiated recall is ongoing.

PRODUCT: Marisa Patient Lift, Non-AC Powered; Arjo Inc., Roselle, IL 60172 Model KGB2000-US, Marisa Complete with Jib and no Scale Model KGB2100-US, Marisa Complete with Jib and Scale, Recall # Z-0460-02.

REASON: Improper alignment of jib assembly to lift carriage.

MANUFACTURER: Marquest Medical Products, Inc. Englewood, CO, by letter on Aug. 15, 2001. Firm initiated recall is ongoing.

PRODUCT: Marquest Ventilator Circuit w/Volume Vent Manifold. Recall # Z-0461-02.

REASON: Cracked Exhalation Valve Caps on ventilator circuits.

MANUFACTURER: Atrium Medical Corp. Hudson, NH, by fax on Sept. 8, 2000. Firm initiated recall is ongoing.

PRODUCT: Atrium water seal chest drain, Ocean 2002 with preconnected ATS blood bag. Recall # Z-0462-02.

REASON: Seal integrity of Blood Bag compromised resulting in blood leakage.

MANUFACTURER: BioChem ImmunoSystems Italia Spa Guidonia Montecello, Rome. Firm initiated recall is complete.

PRODUCT: Personal Lab Version 2.2a. The device is an Immunochemistry Analyzer Open System. Recall # Z-0463-02.

REASON: Samples were not picked up and added to the dilution tube.

MANUFACTURER: Hitachi Medical Corp. Chiyoda-Ku, Tokyo, Japan. Firm initiated recall is ongoing.

PRODUCT: VISION T-22 Gamma Camera System, Recall # Z-0464-02. REASON: The collimator bolts may fail and allow the collimator to drop. Injury may result.

MANUFACTURER: Alliance Healthcare McGaw Park, FL. Firm initiated recall is complete.

PRODUCT: Resuscitaion bag component in an assembled custom surgical kit, Non sterile, lableled in part: "open heart sgl pull items jewish hosp Healthcare, lot #, expiration, reorder # ht0586. Note that only the Resuscitaion bag component was under recall and not the entire kit. Recall # Z-0466-02.

REASON: Component Resuscitation Bag recalled due to improper duck bill action.

MANUFACTURER: Medtronic Cardiac Surgical Products Grand Rapids, MI, by personal visit beginning on or about Oct. 15, 2001. Firm initiated recall is complete.

PRODUCT: a) Medtronic Bio-Medicus Femoral Cannula and Introducer; 17 Fr..

b) Medtronic Bio-Medicus Femoral Cannula and Introducer; 19 Fr. Recall # Z-0467-02.

REASON: Cannula size not as labeled.

CLASS III

MANUFACTURER: Darja Laboratories, Inc. Minden, NV. Firm initiated recall is ongoing.

PRODUCT: 3M Tegagel Hydrogel Wound Filler, 3 oz. tube, Catalog Number 90412, Recall # Z-0432-02.

REASON: The product tubes were filled with a different brand of a similar product which has many of the same ingredients.

MANUFACTURER: Dade Behring Marburg GMBH Marburg. Firm initiated recall is ongoing.

PRODUCT: Pathromtin Reagent, Recall # Z-0434-02.

REASON: Prolonged APTT clotting times.

MANUFACTURER: Diagnostic Products Corp. Los Angeles, CA, by telephone and fax on October 31, 2001. Firm initiated recall is ongoing.

PRODUCT: Immulite Tree Specific IgE; 100 test Kit Id# LKTR1 116 Not cleared for domestic distribution. Recall # Z-0436-02.

REASON: Packaging equipment failure causing missing bead component.

MANUFACTURER: Diagnostic Products Corp. Los Angeles, CA, by telephone on October 31, 2001. Firm initiated recall is ongoing.

PRODUCT: Immulite Total IgE; Radio immunoassay; Packed in 100 test kit under ID#: LKIE 1 160 and in 500 test kit under ID# LKIE 5 160. Recall # Z-0438-02.

REASON: Packaging equipment failure.

MANUFACTURER: Ortho Development Corp., Draper, UT, by telephone on Sept. 14, 2001. Firm initiated recall is complete.

PRODUCT: Ortho Development Cancellous Bone Screw Dia. 6.5mm x 35mm. Catalog No. 146-1035, Lot No.W011026. Recall # Z-0441-02.

REASON: 40mm Cancellous Bone Screws were labeled as 35mm.

MANUFACTURER: Bion Enterprises, Ltd. Des Plaines, IL, by telephone on Jan. 18 and Oct. 16 and 17, 2001. Firm initiated recall is complete.

PRODUCT: Bion Epstein-Barr (VCA) Antigen Substrate For IFA Test System, 12 Well Slide; Bion Enterprises, Ltd., Park Ridge, IL. The 12 Well Slides are packaged individually as product number EB-5012, and as a component of the EBV-M (VCA) Test System, product number EMB-120, with 10 slides per kit. Recall # Z-0444-02.

REASON: The slides were difficult to read using IgM testing.

MANUFACTURER: Instrumentation Laboratories Orangeburg, NY. Firm initiated recall is ongoing.

PRODUCT: Calibration Solution: IL Test Cal 1 Solution (500 mL) for IL Synthesis Analyzers Models 1720 and higher. Recall # Z-0450-02.

REASON: Calibrator may cause abnormally low or high calcium and chloride QC values.

MANUFACTURER: Medisense United Kingdom Limited Abingdon, United Kingdom. Firm initiated recall is ongoing.

PRODUCT: MediSense Optium Blood Glucose Test Strips for use with the MediSense Optium Blood Glucose Monitoring System [50 test trips/box]. Recall # Z-0452-02.

REASON: Incorrectly programmed calibrator fails to calibrate the glucose meter.

MANUFACTURER: Gerard Medical, Inc. Charlton City, MA. Firm initiated recall is ongoing.

PRODUCT: Vaxcel Implantable Access Port Mini Port, Titanium 6 F, Polyurethane Catheter. Recall # Z-0465-02.

REASON: Device Mislabeled as 6 French Instead of an 8 French Dilator.

MANUFACTURER: Textilease Medique Wood Dale, IL, by letter dated Sept. 10, 2001. Firm initiated recall is ongoing.

PRODUCT: Industrial first aid kits consisting of cabinets filled with medical supplies including Medi First Plus Pain Relieving Burn Spray with Aloe Vera Antiseptic Anesthetic, lot 0010004, and/or Medi First Plus Pain Relieving Antiseptic Spray, lot 0003092; Recall # Z-0468-02/Z-0473-02.

REASON: First Aid kits contain Burn Relief Spray &/or Antiseptic Spray recalled by York. Sprays are sub- and super-potent.

MANUFACTURER: Zee Service Inc. Irvine, CA, by letter and fax on Sept. 21, 2001. Firm initiated recall is ongoing.

PRODUCT: First Aid Kits, Recall # Z-0474-02/Z-0484-02.

REASON: First Aid kits contain Burn Relief Spray &/or Antiseptic Spray recalled by York. Sprays are sub- and super-potent. Also, leaking containers or loose caps.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 16, 2002:

CLASS II

MANUFACTURER: Genzyme Biosurgery a div. of Genzyme Corporation Fall River, MA, by letter on 11/21/01. Firm initiated recall is ongoing.

PRODUCT: Recall #'s Z-0414-02/Z-0420-02 A.NextStitch Cardiovascular Valve Suture, Sterile. Labeled in part: "NEXTSTITCH Cardiovascular Valve Suture TEVDEK II Braided PTFE Impregnated Polyester STERILE***" (6-Pack and 9-Pack Configurations) See Code Section for Product Codes and Lot Numbers B.Sutures: Deklene, Polydek, Polyene, Silk, Tevdek; and Pledgets Sutures in various Combination of numbers of sutures and needles. 74 Product Codes- Refer to Code Section

REASON: Sterility of the device may be compromised due to breach in the pouch seal.

MANUFACTURER: Exactech, Inc. Gainesville, FL, by telephone and by letter faxed and mailed on 6/8/2001. Firm initiated recall is ongoing.

PRODUCT: Optetrak 3-Peg Patella, Size 29mm and Optetrak 3-Peg Patella, Size 32 mm, Recall # Z-0422-02.

REASON: Mislabeled with incorrect device size.

MANUFACTURER: Institut Strauman AG Waldenburg, SWITZERLAND. Firm initiated recall is ongoing.

PRODUCT: Straumann Endosseous Dental Implant Esthetic Plus Solid Screw labeled as: Strauman Solid Screw Implant 0.48 mm, 6.0 mm PLUS (endosseous length 7.0 mm), Ti. Sterile. Recall # Z-0423-02.

REASON: Some Dental Implants mislabeled as Wide Neck Implant on the back of the outside packaging

MANUFACTURER: Siemens Medical Systems, Inc., Hoffman Estates, IL. There was no end user notification. Service Bulletin NM011/00/R issued on 4/27/00. Firm initiated recall is complete.

PRODUCT: E.CAM Ball Screws, a component of the ball screw yoke assemblies of the E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; The ball screws were used to make the following assemblies a) part 5208587 - Right for Upper Yoke Assembly (Pivot Side) b) part 5208892 - Right for Lower Yoke Assembly (Clutch Side) c) part 5208884 - Left for Uppper Yoke Assembly (Clutch Side) d) part 5208900 - Left for Lower Yoke Assembly (Pivot Side) Recall # Z-0424-02

REASON: E.Cam radial drive ball screw may fail

MANUFACTURER: Siemens Medical Systems, INC. Hoffman Estates, IL , There was no end user notification. Service Bulletin FMI-274 issued on 11/20/98. Firm initiated recall is complete.

PRODUCT: E.CAM PHS beds used with the E.CAM Emission Imaging Computed TOmography Systems used for all common nuclear medicine procedures. Recall # Z-0425-2/0426-02.

REASON: Acme screw may fail and cause front or rear of bed to fall during use

MANUFACTURER: Premium Plastics, INC. Chicago, IL , via telephone on 11/14/01 and by letters on 11/16/01. Firm initiated recall is ongoing.

PRODUCT: Bulb Irrigation Trays, 20 trays per case; labeled under the following labels: a) Gent-L-Kare Irrigation Tray with 60 cc Bulb Syringe, catalog 4092 Premium Plastics Inc., Chicago, IL b) Bulb Irrigation Tray, catalog 750170, Distributed by C.R. Bard, Inc., Covington, GA 30014 c) Bardia Bulb Irrigation Tray, catalog 802050, Distributed by C.R. Bard, Inc., Covington, GA 30014, Recall # Z-0430-02

REASON: Holes may develop in the trays, compromising the sterility of the kits

MANUFACTURER: Johnson & Johnson Medical, Cincinnati, OH. Firm initiated recall is ongoing.

PRODUCT: Procedural Trays, and Kits containing Procedural Trays. Recall # Z-0431-02. 1) Johnson & Johnson Medical Procedural Trays for BIOVUE Peripherally Inserted Family of Catheters; and 2) Kits consisting of: (a) Johnson & Johnson BIOVUE Peripherally Inserted Central Catheter (PICC), or Midline Catheter, both with OCRILON II Polyurethane; (b) PROTECTIV Safety Introducer System; and (c) Procedural Tray.

KITS with Peripherally Inserted Central Catheter (PICC): Product Description #97901 PICC - Dual Lumen Procedure Kit 16 G /5 Fr #97907 PICC - Dual Lumen Procedure Kit 18 G /4 Fr #97910 PICC - Single Lumen Procedure Kit 18 G /4 Fr #97913 PICC - Single Lumen Procedure Kit 20 G /3 Fr #97916 PICC - Single Lumen Procedure Kit 24 G /2 Fr

KITS with Peripherally Inserted Midline Catheter: Product Description #97919 Midline - Dual Lumen Procedure Kit 18 G/4 Fr #97922 Midline - Single Lumen Procedure Kit 18 G/4 Fr #97925 Midline - Single Lumen Procedure Kit 20 G/3 Fr

PROCEDURE TRAYS: Product Description #97993 Procedure tray for use with BIOVUE PICC's and Midlines 'Latex-Free'. #97994 Procedure tray for use with BIOVUE PICC's and Midlines.

REASON: Sterility of the device may be compromised as evidenced by a loss of package integrity.

MANUFACTURER: Medisense United Kingdom, Limited, Abingdon, United Kingdom. Firm initiated recall is ongoing.

PRODUCT: MediSense Precision PCx Blood Glucose Test Strips for use with the Precision G, Precision PCx or i-STAT 1 Analyzer Blood Glucose Systems. Recall # Z-0446-2/Z-0448-2.

REASON: Blood Glucose Test Strips Control Solution ranges are incorrectly assigned

MANUFACTURER: Hill-Rom CO. Batesville, IN. Hill-Rom Field Service technicians to repair products beginning 12/03/2001. Firm initiated recall is ongoing.

PRODUCT: Integris Monitor Arm, Product P997, Recall # Z-0454-2.

REASON: Monitor arm may loosen and fall or drop the monitor

MANUFACTURER: Micro Specialties, Inc. Milford, CT. Firm initiated recall is complete.

PRODUCT: Insight Technologies Instruments Keratome Blade, Disposable and Sterile. For use with the Becton Dickinson Model BD K-3000 Microkeratome System, Recall # Z-0455-2.

REASON: Kerotome Blade may fail to oscillate properly and cause corneal abrasion

MANUFACTURER: GAMBRO Dasco S.p.A. I-41036 Medolla (MO), IT. Firm initiated recall is ongoing.

PRODUCT: Prisma Dialysis System Control Unit, Catalog No. 018080101, Serial Numbers 963111 thru 963143, and 963194 thru 963530, Recall # Z-0456-2.

REASON: Displayed value of "actual patient fluid removal" can be incorrect

MANUFACTURER: Interventional Technologies, INC., San Diego, CA., by telephone and letter dated 11/6/2001. Firm initiated recall ongoing.

PRODUCT: 2.17 mm Coronary TEC Catheter. Model C102165. Recall # Z-0457-02

REASON: Mislabeled with smaller size.

MANUFACTURER: Lifenet, Virginia Beach, VA, by letter on Oct. 9, 2001. Firm initiated recall is ongoing.

PRODUCT: Human Heart Valves, processed and frozen, for transplantation, Recall #Z-0458-2.

REASON: Donor of tissues for transplantation was not properly assessed for suitability.

MANUFACTURER: Midas Rex, L.P. Fort Worth, TX, by letter on Aug. 7, 2001. Firm initiated recall is complete.

PRODUCT: Dissecting Tools, a round, fluted dissecting accessory tool to the Midas Rex III System and the Midas Rex Classic System, which are both pneumatic drill systems for use in surgery, Recall # Z-0459-2.

REASON: Product mix-up.

CLASS III

MANUFACTURER: Abbott Health Products, INC. Barcelona, Puerto Rico. Firm initiated recall is ongoing.

PRODUCT: Architect Total T4 calibrators, list 6C49-01; for the calibration of the Architect i System when used for the quantitative determination of thyroxin (Total T4) in human serum and plasma; Abbott Laboratories, Abbott Park, IL 60064, Recall # Z-0421-02.

REASON: 9% negative bias in patient results

MANUFACTURER: Siemens Medical Systems, Inc., Hoffman Estates, IL, by letters dated 11/24/98 and 3/18/99, and software upgrades issued 1/29/99 and 11/5/99. Firm initiated recall is complete.

PRODUCT: Autoperfusion Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems to conduct automated myocardial processing in diagnosing myocardial disease in cardiac SPECT studies. Recall # Z-0427-02.

REASON: The software did not save oblique data correctly.

MANUFACTURER: Siemens Medical Systems, INC. Hoffman Estates, IL, by letter on 2/23/00. Firm initiated recall is ongoing.

PRODUCT: Autoperfusion Software, which includes The Cardiac Review (Profile Review) application, used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems to conduct automated myocardial processing in diagnosing myocardial disease in cardiac SPECT studies. Recall # Z-0428-02.

REASON: Rest/stress datasets are mislabeled; summed or non-gated data not saved.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 9, 2002:

CLASS II

MANUFACTURER: Becton Dickinson Infusion Therapy Systems, Inc., Sandy, UT, by phone and fax on 9/7/2001. Firm initiated recall is ongoing.

PRODUCT: a) BD Angiocath Autoguard, REF 381707, 16 GA 1.16 IN., Cat. 381707;
b) BD Insyte Autoguard, REF 381434, 20 GA 1.16 IN., Cat. 381434.
Recall # Z-0363-2.

REASON: Unit packages have microscopic perforations.

MANUFACTURER: Baxter Healthcare Corp., Cleveland, MS. Firm initiated recall is ongoing.

PRODUCT: Baxter Spinal Anesthesia Trays, a sterile, single use only, anesthesia conduction kit labeled as "Non-Latex Components,  a) Baxter Spinal Anesthesia Tray: Sprotte Spinal Needle with Stylet, 24 Ga x 8.9 cm (3-1/2"), 5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP, 2 mL. Recall # Z-0364-02; b) Baxter Spinal Anesthesia Tray: Whitacre Spinal Needle with Stylet, 25 Ga x 8.9 cm (3-1/2") TW High Flow, 5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP, 2 mL, Recall # Z-0365-2.

REASON: Trays labeled as Non-Latex Components contain syringes with a latex stopper.

MANUFACTURER: Sunrise Medical, Fresno, CA, by certified return receipt letters on 9/25/01. Firm initiated recall is ongoing.

PRODUCT: Quickie brand P-222, Powered Wheelchair, Recall # Z-0366-02.

REASON: While in operating mode, an unanticipated stop can occur.

MANUFACTURER: Sunrise Medical Quickie Designs, Inc., Fresno, CA, by letters on 9/25/01. Firm initiated recall is ongoing.

PRODUCT: Quickie brand G-424, S-525, S-626, V-521, Powered Wheelchair, Recall # Z-0367-02/Z-0370-02.

REASON: The dual-post clamping armrest receiver can collapse from the wheelchair.

MANUFACTURER: GE Medical Systems Europe Buc Cedex, France. Firm initiated recall is ongoing. Recalling Firm: General  Electric Medical Systems, Waukesha, WI, by field  modification instructions on 04/01/01.

PRODUCT: LCV+, LCA, LCA+, LC+, LCN+, LCLP+ Angiographic X-ray Systems, Model Numbers 2120351, 2120351-2, 2219157, 2219157-2, 2251041, 2154096, 2219156, and 2251039, Recall numbers # Z-0372-02/Z-0377-02

REASON: The C-arm can move at a high rate of speed forcing the collimator into the bottom of the tabletop.

MANUFACTURER: Recalling Firm: Depuy Orthopaedics, Inc., Warsaw, IN, by letters on October 12, 2001. Firm initiated recall is ongoing.

PRODUCT:  a) ACS Polyethylene Insert, 20 degree, 26mm. Product code 1115-42-025; b) Global Shoulder Enduron Glenoids. Several Product codes; c) Global Shoulder Enduron +3 Glenoids. Several Product codes; d)LCS Mensical Bearings. Several Product codes e) LCS Textured Patella. Product code 1180-14-025; f)Pinnacle Marathon Acetabular Liners, 28 mm. Product codes 1219-28-054, through 1219-28-062 and 1219-28-148 through 1219-28-162; g) Pinnacle Marathon Acetabular Liners, 36 mm. Product code 1219-36-466; h)Duraloc Marathon Acetabular Liners, 28 mm. Several Product codes i)Duraloc Marathon Acetabular Liners, 32 mm. Several Product codes; j)S-ROM Marathon Liner M, 28 mm. Product codes 1220-70-028, 1220-70-128 and 1220-70-328; k)S-ROM Marathon Liner L, 28mm.1220-71-028 and 1220-71-328; l) S-ROM Marathon Liner L, 32 mm. Product codes 1220-72-032, 1220-72-132 and 1220-72-332; m) NeuFlex Finger. Product codes 1234-00-000, 1234-10-000, 1234-40-000 and 1234-60-000; n) Duraloc Enduron Liners. Product codes 1239-50-025 through 1239-66-025; o) Duraloc Enduron Liners. Product codes 1240-10-025 through 1240-18-025 and 1240-48-025 through 1240-58-025; P)Duraloc Enduron Liners. Product codes 1241-08-025 through 1239-26-025 and 1241-48-025 through 1241-64-025; q)Duraloc Enduron Liners. Product codes 1241-08-526 through 1241-16-526, 1241-24-526 and 1241-40-526 through 1241-60-526; r)Duraloc Constrained Liners, 28 mm. Product codes 1241-08-527 through 1241-22-527; s)Duraloc Bantam Liners Product codes 1241-44-527 through 1241-46-527; t)Duraloc Enduron Liners. Product codes 1242-12-025 and 1242-54-025 through 1242-62-025; u) Duraloc Enduron Liners. Product codes 1242-12-526 through 1242-16-526; v) Duraloc Constrained Liners, 32 mm. Product codes 1242-12-527 through 1242-22-527; w) Duraloc Enduron Liners. Product codes 1261-48-526 through 1261-56-526; x) LCS Rotating Bridging Bearings. Product codes 1278-14-025 through 1278-16-025 and 1278-47-025 through 1278-55-025; y) LCS Meniscal Bridging Bearings. Product codes 1278-24-025 through 1278-26-025; z) LCS Deep Dish Rotating Bearings. Product codes 1278-56-025 through 1278-87-025;AA) LCS Rotating Platform Bearings. Product codes 1290-14-025 and 1290-16-025; BB) AMK 3 Peg Patella. Product code 1484-92-025; CC) AMK Tibial Inserts. Product codes 1488-19-025, 1488-41-025 through 1488-45-025, 1488-51-025 through 1488-55-025, 1488-61-025 through 1488-63-025 and 1488-81-025 through 1488-83-025; DD) Coordinate Tibial Inserts. Product codes 1492-42-025 through 1492-65-025; EE) LCS 3 Pegged Patella. Product codes 1497-73-025 through 1497-76-025; FF) Agility Ankle Tibial Inserts. Product codes 1555-31-0000 through 1555-36-000; GG) AMK Constrained Tibial Inserts. Product codes 1688-41-025 through 1688-43-025, 1688-51-025 through 1688-52-025 and 1688-61-025 through 1688-62-025; HH) Acclaim Elbow Pin Assembly. Product code 1722-80-000; II)LCS 3 Pegged Rotating Patella. Product codes 1779-82-025 through 1779-86-025; JJ) AMK Congrucency PS Tibial Inserts. Product codes 1956-41-025, 1956-42-025, 1956-51-025, 1956-53-025 and 1956-62-025.
Recall # Z-0378-02/Z-0413-02

REASON: Lack of assurance of sterility.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 19, 2001:

CLASS II

MANUFACTURER: Abbott Health Products, Inc. Barceloneta, Puerto Rico, by letter dated 10/12/01. Firm-initiated recall is ongoing.

PRODUCT: a) TDx/TDxFlx Ethanol Reagent, Recall # Z-0289-2;

b) ADx Ethanol Reagent, Recall # Z-0290-2.

REASON: Calibration curve failure.=

MANUFACTURER: Johnson & Johnson Medical, Div. of Ethicon, Inc. Sherman, TX. Firm initiated recall is ongoing.

PRODUCT: A sterile dressing, labeled in part: "SURGIPAD* Combine Dressing DRESSING 8 in x 7.5 in. Recall # Z-0337-2.

REASON: Seal Integrity - possibly non-sterile device.

MANUFACTURER: TSK Laboratory Japan, Tochigi-Ken, Japan. Firm-initiated recall ongoing.

PRODUCT: Medi-tech TSK Surecut Biopsy Needle (Sterile) as follows: Recall #’s Z-0341-02/ Z-0349-02.

REASON: Expired sterile product was distributed.

MANUFACTURER: Allegiance Healthcare Corporation, Custom Sterile Division McGaw Park, IL. Firm-initiated recall ongoing.

PRODUCT: Allegiance Custom Sterile Procedure Kits; labeled as containing either one or two size 7.5 powdered synthetic surgical gloves and may or may not have a warning labeled "Caution: This product contains natural rubber latex which may cause allergic reactions. Recall Number(s) Z-0350-02/Z-0358-02.

REASON: Custom Sterile Kits contain Latex Gloves not declared on label.

MANUFACTURER: Braun Medical, Inc. Allentown, PA, via letters on 10/10/01. Firm-initiated recall ongoing.

PRODUCT: a) Gravity and Infusion Pump Intravascular (IV) Sets including brand names: Primary ADDitIV IV Sets, Horizon Pump Primary ADDitIV IV Sets, Safsite Horizon Pump IV Sets, SafeLine Horizon Pump IV Sets, Clave Horizon Pump IV Sets, Intelligent Pump Primary ADDitIV IV Sets, Clave Intelligent Pump IV Sets, Baxter Compatible Pump IV Sets with SafeLine, Baxter Compatible Pump IV Sets with Clave, Baxter Compatible Pump Primary ADDitIV IV Sets, SafeLine Primary ADDitIV IV Sets, and Clave Primary ADDitIV IV Sets. Common Name: Intravascular Administration Set.

Recall # Z-0359-02.

b) Gravity and Infusion Pump Intravascular (IV) Sets including brand names: Primary ADDitIV IV Sets, Horizon Pump Primary ADDitIV IV Sets, Ultrasite Horizon Pump IV Sets, Safsite Horizon Pump IV Sets, SafeLine Horizon Pump IV Sets, Clave Horizon Pump IV Sets, Vista Pump IV Sets, Ultrasite Vista Pump IV Sets, Ultrasite IV Sets, Clave IV Sets, and Clave Primary ADDitIV IV Sets. Common Name: Intravascular Administration Set.

Recall # Z-0360-02.

REASON: a) Inadequate bonding of tube to bottom cap of the drip chamber may cause leaking;  b) tubing may disconnect from Universal Drip Chamber

MANUFACTURER: Boston Scientific Scimed Maple Grove, MN, bv letter on October 29, 2001. Firm-initiated recall ongoing.

PRODUCT: SCIMED UltraFuse Coronary Infusion/Guide Wire Exchange Catheter. Recall #Z-0361-02.

REASON: Some of the recalled Coronary Infusion Catheters have side holes which are partially or completely blocked.

MANUFACTURER: Baxter/Althin Medical, Inc. Miami Lakes, FL.

Firm-initiated recall ongoing.

PRODUCT: Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora; Baxter Healthcare Corporation, Deerfield, IL or Baxter Healthcare Corporation, McGaw Park, IL. Recall # Z-0362-02.

REASON: Spontaneous Dialysate Proportioning Ratio change.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 12, 2001:

CLASS II

MANUFACTURER: Morgan Matroc Ltd., Rugby, Warwichshire, United Kingdom, CV213Q. Firm initiated recall is ongoing.

PRODUCT: Femoral Heads,

Recall # Z-0312-2;

Recall # Z-0313-2.

REASON: Potential breakage of ceramic femoral heads.

MANUFACTURER: Instrumentation Laboratory Co., Orangeburg, NY.

Firm initiated recall is ongoing.

PRODUCT: All GEM Analyzers including:

a) Recall # Z-0314-2, GEM 6 Plus Model 2300;

b) Recall # Z-0315-2, GEM Premier Model 5300;

c) Recall # Z-0316-2, GEM Stat Model 4300;

d) Recall # Z-0317-2, GEM Premier Plus Model 5500;

e) Recall # Z-0318-2. GEM Premier 3000 Model 5700.

REASON: Thiopental sodium, an anesthetic agent, may interfere with Na+, K+ and Cl-reading.

MANUFACTURER: Tegimenta RD Instrument Center Switzerland.

Firm initiated recall is ongoing.

PRODUCT: Roche Elecsys Model 1010 Analyzers, Catalog # 1705253,

Recall # Z-0319-2.

REASON: Electrical short may cause fire in the sample incubation chamber.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by letter on November 1, 2001. Firm initiated recall is complete.

PRODUCT: CryoValve Allograft,

a) Recall # Z-0320-2, Model Number AV00;

b) Recall # Z-0321-2, Model Number PV00.

REASON: Donor did not meet current guidelines regarding serodilution of plasma.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by letter on November 1, 2001. Firm initiated recall is complete.

PRODUCT: CryoValve Allograft,

a) Z-0322-2, Model Number AV00;

b) Z-0323-2, Model Number PV00.

REASON: Donor did not meet current guidelines regarding serodilution of plasma.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 5, 2001:

CLASS II

MANUFACTURER: Hudson Respiratory Care, Inc., Temecula, CA, by letter on October 12, 2001. Firm initiated recall is ongoing.

PRODUCT: Adult and Pediatric Heated Wire Breathing Circuits:

a) Recall # Z-0324-2;

b) Recall # Z-0325-2.

REASON: Risk of overheating and fire.

MANUFACTURER: Abbott laboratories, Inc., South Pasadena, CA, by letter dated October 9, 2001. Firm initiated recall is ongoing.

PRODUCT: AEROSET (brand) Uric Acid, product list number, part or model: LN 07D76-01. All lots (inclusive lot numbers detailed later).

Recall # Z-0326-2.

REASON: Discoloration -- calibration must be done with cartridge change.

MANUFACTURER: Becton Dickinson Consumer Products, Holdredge, NE.

Firm initiated recall is ongoing.

PRODUCT: Brand Name: BD 3ml Syringe with BD Twinpak, BD 10ml Syringe with BD Twinpak.

Common Name: Piston syringe with blunt plastic cannula and metal Cannula, Recall # Z-0327-2.

REASON: Improperly sealed unit packages

MANUFACTURER: Abbott Laboratories, Inc., South Pasadena, CA, by letter dated October 29, 2001. Firm initiated recall is ongoing.

PRODUCT: a) AEROSET Aspartate Aminiotransferase (AST) Part Number LN 07D81-01,

Recall # Z-0328-2;

b) AEROSET Alanine Aminotransferase (ALT) Part number LN 07D56-01,

Recall # Z-0329-2.

REASON: Failure to exhibit Linear Low Flag upon substrate depletion condition.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 28, 2001:

CLASS II

MANUFACTURER: Multidata Systems International Corp., St. Louis, MO, by letter on 6/22/01. Firm initiated recall is ongoing.

PRODUCT: Radiation Treatment Planning Decision Support System (DSS),

Recall # Z-0213-2.

REASON: The software calculates radiation overdoses that require human intervention to detect and prevent injury to radiation therapy patients.

MANUFACTURER: Nobel Biocare USA, Inc., Yorba Linda, CA, by letter dated July 13, 2001. Firm initiated recall is ongoing.

PRODUCT: Replace (brand), Easy Abutment, 5.5mmH, 0.5mm MARGIN, 4.3mm SERIES (SELECT), Recall # Z-0295-2.

REASON: Poor rework instructions caused mix of sterile and nonsterile components.

MANUFACTURER: Vasca Inc., Tewksbury, MA, by letter on 8/2/01. Firm initiated recall is ongoing.

PRODUCT: a) LifeSite Hemodialysis Access System; Catalog # LHAS14120 and several lot numbers.

b) LifeSite Hemodialysis Cannula Exchange Kit, Model LHCEK0000, Lot Numbers: 99;100;406;407;408 and 409.

Recall Number(s): Z-0296-2.

REASON: Labeling Change to Instructions for use in Heparin Lock Concentration.

MANUFACTURER: Bausch & Lomb Surgical Clearwater, FL. Firm initiated recall is ongoing.

PRODUCT: Storz Opthalmics Concentrix Phaco Pack Sterile,

Recall # Z-0297-2.

REASON: The irrigated line tubing may not properly adhere to the product's cassette.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by letter on 10/25/01. Firm initiated recall is complete.

PRODUCT: CryoValve Allograft (Heart Valve):

a) Recall # Z-0299-2;

b) Recall # Z-0300-2.

REASON: Donor does not meet current guidelines regarding serodilution of plasma.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by letter on 10/31/01. Firm initiated recall is complete.

PRODUCT: CryoValve Allograft, Recall # Z-0301-2.

REASON: Donor does not meet current guidelines regarding serodilution of plasma.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA by letter on 10/31/01. Firm initiated recall is complete.

PRODUCT: CryoValve Allograft, Recall # Z-0302-2.

REASON: Donor does not meet current guidelines regarding serodilution of plasma.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by letter on 10/31/01. Firm initiated recall is complete.

PRODUCT: CryoValve Allograft, Recall # Z-0303-2.

REASON: Donor does not meet current guidelines regarding serodilution of plasma.

MANUFACTURER: Cryolife, Inc., Kennesaw, Ga, by telephone on 10/29/01.

PRODUCT: CryoValve Allograft, Recall # Z-0304-2.

REASON: Donor does not meet current guidelines regarding serodilution of plasma.

MANUFACTURER: Manufacturer: Siemens AG D-91025 Erlangen, Germany,

PRODUCT: Arcoskop Ceiling Mounted Image Intensifier System, Recall # Z-0305-2.

REASON: The C-arm separated from the swivel arm and fell.

MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by letter dated 9/26/01. Firm initiated recall is ongoing.

PRODUCT: The Abbott AxSYM System is a fully automated Immunoassay analyzer designed to perform Microparticle Enzyme Immunoassay (MEIA), Fluorescence Polarization Immunoassay (FPIA), Radiative Energy Attenuation (REA) Assay Technology, and Ion Capture (IC) Immunoassay Technologies. The AxSYM System performs random access, continuous access, and STAT processing of both large and small molecular weight analytes, Recall # Z-306-2 to Z-311-2.

REASON: The system may report sample results from the incorrect sample tube.

CLASS III

MANUFACTURER: Remel, Inc., Lenexa, KS, Recall letters dated 10/8/01 were issued via certified mail requesting the customer to discard the affected units. Recall is ongoing.

PRODUCT: Remel Mueller Hinton Agar, Recall # Z-0298-2.

REASON: Some plates in the lot were contaminated with Staphylococcus aureus.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 21, 2001:

CLASS II

MANUFACTURER: Baxter/Althin Medical AB Ronneby, SW.

Firm initiated recall is ongoing.

PRODUCT: Melt-spun Cellulose Diacetate Hemodialyzers; a single use sterile device for hemodialysis of patients with acute or chronic renal failure; 12 units per case; A-Series Dialyzers made from Altra Nova Fibers, AF-Series Dialyzers made from Altra Flux Fiber and AX-Series Dialyzers made from Altrex Fiber;

a) Recall # Z-0257-2;

b) Recall # Z-0258-2;

c) Recall # Z-0259-2;

d) Recall # Z-0260-2;

e) Recall # Z-0261-2;

f) Recall # Z-0262-2;

g) Recall # Z-0263-2;

h) Recall # Z-0264-2;

i) Recall # Z-0265-2.

REASON: Hemodialyzers associated with deaths in Croatia and Spain.

CLASS II

MANUFACTURER: Neurocontrol Corp., Valleyview, OH, by telephone on 5/3 and 5/4/2001. Firm initiated recall is ongoing.

PRODUCT: The FREEHAND System, a hand grasp implanted functional electrical stimulator, Recall # Z-0267-2 to Recall # Z-0268-2.

REASON: If the electrode is implanted too deeply, the device will not operate properly.

MANUFACTURER: Hill-Rom/Netlinx Cary, NC, by letter on 5/1/00. Firm initiated recall is ongoing.

PRODUCT: WatchChild Obstetrical Data Management System, Recall # Z-0269-2.

REASON: Problem with data from fetal and maternal monitors.

MANUFACTURER: Inovision Radiation Measurements, Solon, OH, by letter on 7/27/2001. Firm initiated recall is ongoing.

PRODUCT: Inovision/Victoreen NERO mAx, Model 8000, radiologic quality assurance instrument, Recall # Z-0271-2.

REASON: Due to improper calibration, the units will read 10X higher than actual

MANUFACTURER: DHD Healthcare Corp., Wampsville, NY, by telephone on 8/22/01, followed by faxed letter on 8/23/01. Firm initiated recall is ongoing.

PRODUCT: CircuVent, Recall # Z-0272-2.

REASON: Indicator labels in wrong orientation.

MANUFACTURER: MDR Specialty Distribution Corporation Williamsburg, VA, by letter 9/18/2001. Firm initiated recall is ongoing.

PRODUCT: Steris brand S2000 Sterilant, packaged in cases containing 20 boxes of Steris 20 Sterilant Concentrate, each box containing 2 bottles, 160.7 gm dry powder component in one bottle and 2.02 fl ounce liquid component in the other, Recall # Z-0273-2.

REASON: Distributor relabeled sterilant with extended expiration date.

MANUFACTURER: Radionics, A Division of Tyco Healthcare, Billerica, MA, by telephone between 9/17/2001 and 18/01. Firm initiated recall is ongoing.

PRODUCT: Radionics XKnife RT Software, Recall # Z-0275-2.

REASON: Software error may cause incorrect jaw settings for a record/verify system.

MANUFACTURER: Acumed, Inc. Beaverton, OR, faxed or e-mailed on 10/5/01 to distributors a recall notice marked "Urgent" that requested return of the product. Firm initiated recall is ongoing.

PRODUCT: Sterile 3.5mm x 25.0mm Cortical Screw, lot #W02675. This implant belongs to the Polarus Humeral Rod System product line which is a system of rods and screws for the fixation of humeral fractures and their accompanying instrumentation. This device is single use and provided sterile as stated on the labeling, Recall #Z-0277-2.

REASON: Extended sterilization expiration date.

MANUFACTURER: Ferno-Washington, Inc. Wilmington, OH, by letters mailed on 9/14/2001.

PRODUCT: Model 93 Series, Squadmate Ambulance Cots, Recall # Z-0283-2/Z-0288-2.

REASON: The locking mechanism may fail and cause injury to the patient or operator.

MANUFACTURER: Stryker Endoscopy, Santa Clara, CA, by voice mail on 9/28/01 followed by written notification on 10/1/01. Firm initiated recall is ongoing.

PRODUCT: Stryker Endoscopy brand disposable Arthroscopic Bur with 4.0mm Barrel Bur Model #s/Part#s:

a) 275-941-000,6 Flute, Hooded Barrel Bur,

Recall # Z-0291-2;

b) 275-941-012, 12 Flute, Hooded Barrel Bur,

Recall # Z-0292-2;

c) 275-941-200, 6 Flute, Unhooded Barrel Bur,

Recall # Z-0293-2.

REASON: The bur head can separate from the shaft during use.

MANUFACTURER: Becton Dickinson & Co., Broken Bow, NE.

Firm initiated recall is ongoing.

PRODUCT: Vacutainer Sodium Polyanethol Sulfonate (SPS) Blood Culture Specimen Collection Tube, Catalog #366404, Recall # Z-0294-2.

REASON: When stopper is pulled out, healthcare worker may contact collected blood specimen.

CLASS III

MANUFACTURER: Ameresco Solon, OH. Firm initiated recall is ongoing.

PRODUCT: Deproteinizer Solution B, Recall # Z-0270-2.

REASON: Product may be contaminated with salmonella.

MANUFACTURER: Eastman Kodak Co., Rochester, NY, by telephone on 8/17/01 and by visits between 8/23/2001 through 9/4/01. Firm initiated recall is ongoing.

PRODUCT: Kodak 100-film autoloader for the Kodak LS40, LS50, LS75, and LS85 Film Digitizers and Lumisys Autoloader Film Autoloader,

Recall # Z-0274-2.

REASON: Potential shock hazard.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 14, 2001:

**CORRECTION** Z-0217-2 listed in the November 7, 2001, Enforcement Report, as a Class II Recall, should be listed as a Class III Recall.

RECALLING FIRM/MANUFACTURER

Stryker Corp., Kalamazoo, MI, by letters dated 8/23/01.

PRODUCT

Stryker Model No. 2500 Go Bed, Recall #Z-0266-2.

CODE

Serial Nos. C01001 through C03551.

REASON

Side rail does not always lock in the highest position and it may drop suddenly causing injury or falls to patients or caregivers.

VOLUME OF PRODUCT IN COMMERCE

201 beds

DISTRIBUTION

Nationwide

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 7, 2001:

CLASS II

MANUFACTURER: Conmed Corp., Utica, NY

PRODUCT: Z-0214-2, Physiometrix PSARRAY EEG ELECTRODE

REASON: Stud in the electrode separates from the substrate and remains in the lead wire

MANUFACTURER: Medtronic Med Rel, Inc., Humacao, RQ

PRODUCT: Z-0215-2, Itrel 3 Implantable Pulse Generator (Neurostimulator), Model 7425

REASON: Shocks to the patient at the implant site can occur due to missing insulation for the battery.

MANUFACTURER: Novametrix Medical Systems, Inc., Wallingford, CT

PRODUCT: Z-0216-2, Novametrix NICO Monitor, Model 7300 with software versions below 4.3

REASON: Monitor may miscalculate Pulse Rate and Oxygen Saturation (SpO2) values.

MANUFACTURER: Hitachi Ltd. Japan

PRODUCT: Z-0217-2, Roche Modular Analytics immunoassay based clinical analyzer, model E170, catalog number 7656961.

REASON: May give incorrect thyroid test results.

MANUFACTURER: Canterbury Scientific Ltd. Christchurch 1, New Zealand,

PRODUCT: Z-0218-2, DCA2000 Hemoglobin A1c Normal and Abnormal Control kit, catalog number 5068, Lot 0009

REASON: Defective Vials

MANUFACTURER: Howmedica Osteonics Corp., Allendale, NJ

PRODUCT: Z-0219-2 - V40 Zirconia Femoral Heads, Model Nos. h 6364-4-028, h 6364-4-032, h 6364-4-122, h 6364-4-126, h 6364-4-128, h 6364-4-132, h 6364-4-222, h 6364-4-226, h 6364-4-228, h 6364-4-232;

Z-0220-2 - Osteonics µ Zirconia C-Taper Femoral Bearing Head, Model Nos.h 16-2600, h 16-2605, h 16-2800, h 16-2805, h 16-3200, h 16-3205, h 16-3299;

Z-0221-2 - Exeter Ceramic Femoral Head, Model Nos.4658-2-801, 4658-2-802, 4658-3-201, 4658-3-202, 4658-3-203

REASON: Higher than expected failure rate with certain batches of Saint Gobain Desmarquest Zirconia Ceramic Heads

MANUFACTURER: Biomet, Inc., Warsaw, IN

PRODUCT: Z-0222-2 - Modular Head Hip Joint Prostheses (22 mm and 28 mm), Reference No. 163110;

Z-0223-2 - Modular Head Hip Joint Prostheses (22 mm and 28 mm), Reference No. 163111;

Z-0224-2 - Modular Head Hip Joint Prostheses (22 mm and 28 mm), Reference No. 163130;

Z-0225-2 - Modular Head Hip Joint Prostheses (22 mm and 28 mm), Reference No. 163131;

Z-0226-2 - Modular Head Hip Joint Prostheses (22 mm and 28 mm), Reference No. 163132;

Z-0227-2 - Modular Head Hip Joint Prostheses (22 mm and 28 mm), Reference No. 163113;REASON: Higher than expected failure rate with certain batches of Saint Gobain Desmarquest Zirconia Ceramic Heads.

REASON: Higher than expected failure rate with certain batches of Saint Gobain Desmarquest Zirconia Ceramic Heads

MANUFACTURER: Osteoimplant Technology (OTI), Inc., Hunt Valley, MD

PRODUCT: Z-0228-2, Zirconia Femoral Head Prosthesis,

Catalog No. CFHS-028;

Z-0229-2, Zirconia Femoral Head Prosthesis,

Catalog No. CFHM-028;

Z-0230-2, Zirconia Femoral Head Prosthesis,

Catalog No. CFHL-028.

REASON: Higher than expected failure rate with certain batches of Saint Gobain Desmarquest Zirconia Ceramic Heads.

MANUFACTURER: Apex Surgical, LLC, Lakeville, MA

PRODUCT: Z-0231-2, Modular Zirconia Femoral Head,

Catalog No. 322899;

Z-0232-2, Modular Zirconia Femoral Head,

Catalog No. 322800;

Z-0233-2, Modular Zirconia Femoral Head,

Catalog No. 322835;

Z-0234-2, Modular Zirconia Femoral Head,

Catalog No. 322807;

REASON: Higher than expected failure rate with certain batches of Saint Gobain Desmarquest Zirconia Ceramic Heads.

MANUFACTURER: DePuy Orthopaedics, Inc., Warsaw, IN

PRODUCT: Z-0235-2, Zirconia Ceramic Articul/eze Femoral Ball, Catalog Nos. 1365-41-00, 1365-42-000, 1365-43-000, 1365-44,000, 1365-45-000, 1365-46-000, 1365-47-000, 1365-48-000;

Z-0236-2, Zirconia Ceramic SROM Taper Femoral Head, Catalog No. 56-0028, 56-00298;

Z-0237-2, Zirconia Ceramic Elite Taper Femoral Head, Catalog No. 9621-25-000, 9621-26-000, 9621-27-000, 9621-30-000, 9621-31-000, 9621-16-000, 9621-17-000, 9621-18-000, 9621-19-000, 9621-20-000, 9621-21-000, 9621-22-000, 9621-23-000, 9621-24-000;

Z-0238-2, Zirconia Ceramic PFC Head, Catalog No. 85-3878, 85-3879, 85-3880

REASON: Higher than expected failure rate with certain batches of Saint Gobain Desmarquest Zirconia Ceramic Heads.

MANUFACTURER: Zimmer, Inc., Warsaw, IN

PRODUCT: Z-0239-2, Versys Hip System, Catalog Nos. 00-8118-022-02, 00-8118-028-01, 00-8118-028-02, 00-8118-028-03, 00-8118-032-02 and 00-8118-032-03;

Z-0240-2, Zirconia Ceramic Femoral Head, Catalog Nos. 00-9030-028-00, 00-9030-028-35, 00-9030-029-00, and 00-9030-029-35

REASON: Higher than expected failure rate with certain batches of Saint Gobain Desmarquest Zirconia Ceramic Heads.

MANUFACTURER: Smith & Nephew, Inc., Memphis, TN

PRODUCT: Z-0241-2, Zirconia Taper Femoral Head, Catalog No. 71320828;

REASON: Higher than expected failure rate with certain batches of Saint Gobain Desmarquest Zirconia Ceramic Heads.

MANUFACTURER: Smith & Nephew, Inc., Memphis, TN

PRODUCT: Z-0242-2, Zirconia 12/14 Taper Femoral Head, 26mm, +0, Part No. 71320026,

Z-0243-2, Zirconia 12/14 Taper Femoral Head, 26mm, +4, Part No. 71320426,

Z-0244-2, Zirconia 12/14 Taper Femoral Head, 26mm, +8, several part number

Z-0245-2, Zirconia 12/14 Taper Femoral Head, 28mm, +0, several part Numbers

Z-0246-2, Zirconia 12/14 Taper Femoral Head, 28mm, +4, several part numbers.

Z-0247-2, Zirconia 12/14 Taper Femoral Head, 28mm, +8, several part numbers

Z-0248-2, Zirconia 12/14 Taper Femoral Head, 32mm, +0, Part No. 71927729,

Z-0249-2, Zirconia 12/14 Taper Femoral Head, 32mm, +4, Part No. 71927734,

Z-0250-2, Zirconia 12/14 Taper Femoral Head, 32mm, +8, Part No. 71927735,

Z-0251-2, Zirconia 14/16 Taper Femoral Head, 32mm, +0, Part No. 427815,

Z-0252-2, Zirconia 14/16 Taper Femoral Head, 32mm, +4, Part No. 427816, Z-0253-2, Zirconia 14/16 Taper Femoral Head, 32mm, +8, Part No. 427817,

REASON: Higher than expected failure rate with certain batches of Saint Gobain Desmarquest Zirconia Ceramic Heads.

MANUFACTURER: Teamedics Shenzhen, China,

PRODUCT: Z-0254-2

A)Homedics brand Model PowerDent battery operated toothbrushes; all lots. The toothbrushes are sold as in packages of 1 as Model HD-30, packages of two as Model HD-30DP, and packages of 12 as Model HD-30-12PK.
Z-0255-2

B)Homedics brand Model PowerDent Jr. battery operated toothbrush; all lots. The toothbrushes are sold as in packages of 1 as Model HD-20, packages of two as Model HD-20DP, and packages of 12 as Model HD-20-12PK.

REASON: Defective seal allows water into handle

MANUFACTURER: Microgenics, Fremont, CA

PRODUCT: Z-0256-2, CEDIA Phenobarbital II Reagent, Lot No. 28105900, Catalog No. 1775936

REASON: The kit’s bottles 1 and 2 were mislabeled.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 31, 2001:

CLASS II

MANUFACTURER: Micro Therapeutics, Inc., Irvine, CA

PRODUCT: Z-0179-2/Z-0180-2, MTI FlowRider, Flow Directed Micro Catheter.

REASON: Catheter lumen obstructed.

MANUFACTURER: Marconi Medical Systems, Inc., Highland Heights, OH

PRODUCT: Z-0181-2, Marconi MX8000 Computed Tomography X-ray System, Codes: All Marconi MX8000 CT Scanners, running with Version 2.0 and 2.01 software.

REASON: Software in version 2.0 / 2.01 software may lead to improper patient treatment.

MANUFACTURER: Medtronic Cardiac Surgical Products, Grand Rapids, MI

PRODUCT: Z-0183-2/Z-0195-2, Medronic malleable single stage venous
Cannula

REASON: Guide wire may break through cannula wall and 1 lot labeled with incorrect size.

MANUFACTURER: Meridian Diagnostics, Inc., Cincinnati, OH

PRODUCT: Z-0197-2, Premier HSV-1 IgM ELISA, a diagnostic test kit for the detection of IgM antibody to Herpes Simplex Virus Type 1 in human serum.

REASON: The test kit may exhibit false positive test results.

MANUFACTURER: Invacare Corp., Sanford, FL

PRODUCT: Z-0198-2/Z-0201-2, Invacare Mobilare Concentrators, 5 Liter, Codes: Serial Numbers: 94K thru 94L, 95A thru 95L, 96A thru 96L, and 97A.

REASON: A faulty capacitor may fail and cause the unit to overheat and damage the concentrator. There is a potential fire hazard.

MANUFACTURER: Toshiba America Medical Systems, Inc., Tustin, CA

PRODUCT: Z-0202-2, SSA-340A Optional Biopsy adaptor UAGV015A for Endovaginal probe, Codes: Model number UAGV015A.

REASON: Biopsy probe adaptor fork breaks, risk of vaginal damage.

MANUFACTURER: Sunquest Information Systems, Inc., Tucson, AZ

PRODUCT: Z-0204-2, FlexiLab Laboratory Information System, Anatomic Pathology Pathologist Workstation,

REASON: Data on one patient's pathology file overwrites to another patient's file.

MANUFACTURER: Bayer Corp., Mishawaka, IN

PRODUCT: Z-0205-2/Z-0212-2, Bayer brand Clinitek 50 Urine Chemistry Analyzer. Analyzer catalog numbers 6510A, 6513, 6514, 6514C, 6515, 6515C, 6516 and 6516C.

REASON: Erratic results if plugged into an ungrounded outlet

CLASS III

MANUFACTURER: Osteomed Corp., Addison, TX

PRODUCT: Z-0182-2, The device is a hand piece drill used in oral surgery. It is labeled in part: "Osteomed OsteoPower Handpiece System 1:1 Straight Drill,"

REASON: Corrosion stress failure may prevent collet from locking burr in place.

MANUFACTURER: Meridian Diagnostics, Inc., Cincinnati, OH

PRODUCT: Z-0196-2, ImmunoCard Toxin A, a rapid enzyme immunoassay for the detection of Clostridium difficile Toxin A in human stool,

REASON: The substrate exhibits a blue color that may result in a false positive test.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 24, 2001:

CLASS II

MANUFACTURER: Stryker Corp. Kalamazoo, MI

PRODUCT: Z-1079-1/Z-1081-1
A) Stryker Zoom Patient Transport Frame. Model 2040; Serial numbers 0012036662, 0012036663 and 010215001 through 0107037043.
B) Stryker Epic II Critical Care bed with Zoom. Model 2030; Serial numbers 010215606 through 0106036627.
C) Stryker Secure II Med/Surg bed with Zoom. Model 3002; Serial numbers 0101035906 through 010515421.

REASON: Inverter/charger board may catch fire when unplugged from power source.

MANUFACTURER: Diagnostic Products Corp., Los Angeles, CA

PRODUCT: Z-0005-2/Z-0006-2, IMMULITE Turbo Troponin I Kit. An in-vitro diagnostic kit for the quantitative measurement of Troponin I in serum or plasma. Models affected are 100 test kit (LSKTI1 lot 118) and 500 test kit (LSKTI5 lot 118).

REASON: Component mix-up in diagnostic kit

MANUFACTURER: Nexell Therapeutics, Inc., Irvine, CA

PRODUCT: Z-0007-2, Cryocyte Freezing Containers, 250 ml with Label Pocket. Labeled in part, "Immunotherapy Code XXXXXX Cryocyte Freezing Container with Label Pocket 250 ml Capacity*** Baxter Healthcare Corporation, Deerfield IL 60015"

REASON: Cracking of fill tubing.

MANUFACTURER: Dade Behring Marburg GMBH, Marburg, Germany

PRODUCT: Z-0013-2, Behring Coagulation System (BCS) Coagulation Analyzer.

REASON: Falsely shortened APTT value.

MANUFACTURER: Uroan XXI Electromedicina Palma De Mallorca, SP

PRODUCT: Z-0016-2, American Medical System Cavernotome C&R Disposable Dilators; set includes 4 sizes of dilators.

REASON: Sterile disposable dilators punctured sterile packaging in transit.

MANUFACTURER: Hyperbaric Technologies, Inc. Amsterdam, NY

PRODUCT: Z-0017-2, Chamberlite Emergency Portable Hyperbaric Chamber Labeled: Operation Pressure 15 PSI

REASON: Firm is distributing device at a higher psi level than it is approved for.

MANUFACTURER: Meridian Bioscience, Inc., Cincinnati, OH

PRODUCT: Z-0018-2, Premier brand Chagas IgG EIA test kits.

REASON: False positive test results.

MANUFACTURER: Nissho Nipro Corp., LTD., Ayuthaya

PRODUCT: Z-0019-2/Z-0023-2, Nipro Safe Touch Safety Fistula Needle. All model numbers and lot numbers are included in this recall.

REASON: Needle may separate from the hub of the fistula needle

MANUFACTURER: Hyperbaric Technologies, Inc. Amsterdam, NY

PRODUCT: Z-0024-2, Gamow Bag, a portable hyperbaric chamber, Codes: All Gamow Bags with S/N's between "31" and "1062"

REASON: Unsubstantiated claims for HACE and HAPE

MANUFACTURER: Siemens Medical Systems, Inc., Hoffman Estates, IL

PRODUCT: Z-0028-2, Pediatric Pallet, part number 5239715; an accessory used with the E.CAM Emission Imaging Computed Tomography Systems to adapt the unit for pediatric use for all common nuclear medicine procedures.

REASON: Pediatric Pallet plunger end pin may break

MANUFACTURER: AccuSync Medical Research Corp. Milford, CT

PRODUCT: Z-0029-2/Z-0030-2, AccuSync 7 ECG Gating Device/Monitor used as an accessory to the E.CAM family of Emission Imaging Computed Tomography Systems to monitor the patients' cardiac output and act as a trigger during gated cardiac acquisitions; Siemens Medical Systems Inc., Hoffman Estates, IL; two models of monitor were affected by the recall:
a) ECG Monitor without Chart Recorder, part 5220327
b) ECG Monitor with Chart Recorder, part 5220335

REASON: Monitor generates ECG patterns & traces when not connected to patient

MANUFACTURER: Boston Scientific SciMed, Inc., Maple Grove, MN

PRODUCT: Z-0032-2/Z-0036-2, Boston Scientific Corporation's Viper Small Vessel Peripheral (Balloon) Dilatation Catheters with Bioslide Hydrophilic Coating,

REASON: Some units have mid-shaft bond strengths below specifications making it is possible that a distal segment of the catheter may become detached.

MANUFACTURER: Engineered Medical Systems, Inc. Indianapolis, IN

PRODUCT: Z-0037-2/Z-0056-2, Airlife Manual Resuscitation Bags, Latex Free; a disposable single patient use device used for pulmonary resuscitation; the immediate container has the warning "IMPORTANT Perform functional test on Resuscitator by squeezing the bag and verifying proper valve action PRIOR TO PLACING IN SERVICE"; Manufactured for Allegiance Healthcare Corporation, IL

REASON: Resuscitation bags may not allow proper duck bill valve action

MANUFACTURER: Perimed AB Jarfalla - Sweden

PRODUCT: Z-0058-2, Laser Doppler Flowmeter, PF 5001 Main Unit; a Blood Flow Meter. Used for housing Laser Doppler Blood Perfusion modules: PF 5010 Laser Doppler Module, or PF 5040 Transcutaneous Oxygen Module.

REASON: A low output level from the laser light will result in device failure during use.

MANUFACTURER: Boston Scientific Corp. San Jose, CA

PRODUCT: Z-0060-2, Constellation brand Multiple Electrode Recording and Pacing Catheter.

REASON: Product may be contaminated with small fibers on the distal tip of the catheter.

MANUFACTURER: Medtronic, Inc., Neurological Division, Minneapolis, MN

PRODUCT: Z-0061-2, IsoMed Constant-Flow Infusion System Clinical Reference Guide for Pain Therapy, Product Catalog Number 182369-102/UC1999901594a EN NP3821

REASON: Clinical guides given to physicians to aid their management of patients with IsoMed pumps lack a warning statement.

MANUFACTURER: Abbott Health Products, Inc., Barceloneta, PR

PRODUCT: Z-0062-2, AxSYM Total T4 Reagent AxSYM Total T4 is a Fluorescence Polarization Immnunoassay (FPIA) for the quantitative determination of thyroxine (T4) in human serum or plasma. This include both protein-bound and unbound forms of thyroxine. The AxSYMm Total T4 assay is used as an aid in the assessment of thyroid status.

REASON: Failure to calibrate the assay when using these reagents lots

MANUFACTURER: Dialysis Solutions, Inc. Richmond Hills, Ontario, Canada

PRODUCT: Z-0067-2, NORMOCARB (Sterile Bicarbonate Renal Dialysis Concentrate). Lots 1A530, 1A620, 1A940, 1B270, 1B280, 1C330, GA0951, GA1188, GA1190 and GA2889 Codes:

REASON: Contaminated with microorganism

MANUFACTURER: Depuy Orthopaedics, Inc., Warsaw, IN

PRODUCT: Z-0068-2, Depuy brand PFC Sigma Knee System fluted femoral stem, 18 mm x 175 mm. Catalog number 96-1713, Lot 099495.

REASON: Mislabeled as to size

MANUFACTURER: Invacare Corp. Sanford, FL

PRODUCT: Z-0069-2/Z-0072-2, Junction Box, a component of Invacare Electric Beds, AC-Powered Adjustable Hospital.

REASON: A faulty junction box may overheat, and result in electrical failure with potential fire hazard.

MANUFACTURER: COBE CARDIOVASCULAR, INC. ARVADA, CO

PRODUCT: Z-0074-2/Z-0087-2, COBE Cardioplegia Delivery Sets (may also be labeled as the Sorin brand, the Dideco brand or be contained in COBE Heart Lung packs).

REASON: Tubing subassembly assembled with wrong size tubing.

MANUFACTURER: University of Miami Tissue Bank Miami, FL

PRODUCT: Z-0088-2, Human Dura Mater Allograft, packaged in bottles, and labeled in part: "HUMAN FREEZE DRIED ETHYLENE OXIDE STERILIZED DURA MATER"

REASON: Dura Mater with Residual Endotoxin level above 0.06EU/ml

MANUFACTURER: St. Jude Medical, Inc., Sylmar, CA

PRODUCT: Z-0089-2, Profile MD V-186HV3 Implantable Cardioverter Defibrillator

REASON: Capacitor may short

MANUFACTURER: Roche Diagnostics GmbH Mannheim, Germany

PRODUCT: Z-0090-2/Z-0176-2, All lots of all cassettes for the listed products that do not bear a green or white sticker with arrows pointing up and the words "store upright" on the sticker are under recall.

REASON: Bottles may leak and result in incorrect results

MANUFACTURER: Nihon Kohden, Inc., CA

PRODUCT: Z-0177-2/Z-0178-2, Procyon Bedside Monitors, Models BSM-4104A and BSM-4114A.

REASON: Software causes infusion rate 2.2 times proper rate.

CLASS III

MANUFACTURER: Ortho-Clinical Diagnostics, Inc., Rochester, NY

PRODUCT: Z-0026-2, VITROS Chemistry Slides - BUN/UREA DT Slides
25 slides per box, Responsible firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, NY,

REASON: Lot # and exp. date on some cartons is unreadable

MANUFACTURER: Ramco Laboratories, Inc., Stafford, TX

PRODUCT: Z-0027-2, IVD Transferrin Receptor Assay (TfR)kit; In vitro enzyme immunoassay for quantifying the concentration of transferrin receptor in human serum or plasma to aid in the diagnosis of iron deficiency anemia.

REASON: IVD product for TfR with controls out of range

MANUFACTURER: Siemens Medical Systems, Inc., Hoffman Estates, IL

PRODUCT: Z-0031-2, Motion Electronics Computer Chassis (MECC) Backplanes installed in E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL

REASON: Backplane traces become overheated, causing CT camera to become inoperable

MANUFACTURER: Marconi Medical Systems, Inc., Highland Heights, OH

PRODUCT: Z-0057-2, Marconi MX8000 Computed Tomography X-ray System.

REASON: A software anomaly in ver 2.0 software may result in improper patient diagnosis.

MANUFACTURER: Valleylab, Inc., Boulder, CO

PRODUCT: Z-0059-2, Valleylab E6019 Bipolar Footswitch, Lot #498238.

REASON: Footswitch will intermittently stick in the ON (activated) position.

MANUFACTURER: Roche Diagnostics GmbH Mannheim, Germany,

PRODUCT: Z-0063-2, Roche Tina-quant IgA. Catalog # 1931687; all lots. The product is an invitro diagnostic for the determination of human IgA.

Z-0064-2, Roche Tina-quant IgE. Catalog # 1931725; all lots. The product is an invitro diagnostic for the determination of IgE.

Z-0065-2, Roche Tina-quant IgG. Catalog # 1931695; all lots. The product is an invitro diagnostic for the determination of human IgG.

Z-0066-2, Roche Tina-quant IgM. Catalog # 1929305; all lots. The product is an invitro diagnostic for the determination of human IgM.

REASON: Monoclonal gammopathies may exhibit high dose hook effect below label conc.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 17, 2001:

CLASS II

MANUFACTURER: Integra Neurocare LLC, San Diego, CA

PRODUCT: Z-0001-2, Integra Neurosciences True Tech REF NL960-V Ventricular Tunneling Pressure Monitoring Kit Ventrix(r) True Tech

REASON: The "lock/unlock" label was reversed on the catheter connector.

MANUFACTURER: Western Medica Westlake, OH.

PRODUCT: Z-0002-2, Western OPC-830 Portable Oxygen Conserving Regulator. The OPC-830 is a regulator and conserving device combined within one unit. The user can switch between the Continuous Mode (delivers a constant flow, regardless of breathing patterns) and Conserve Mode (delivers flow only during inhalation) without disconnecting the unit.

REASON: Defective demand valve does not function as intended in the 'Conservative

MANUFACTURER: Drager Medizintechnik GmbH Lubeck, Germany,

PRODUCT: Z-0003-2, Babytherm 8004/8010 with Phototherapy Option. The device is an infant warming system.

REASON: Breakage

MANUFACTURER: Ecolab Inc. Huntington, IN

PRODUCT: Z-0004-2, MediVators brand Rapicide High-Level Disinfectant and Sterilant. Active ingredient: Glutaldehyde.

REASON: Bottles may leak.

MANUFACTURER: Tegimenta, AB Switzerland,

PRODUCT: Z-0008-2, COBAS Integra 400 laboratory clinical chemistry analyzer, Model 400, Catalog number 1045199. All serial numbers of analyzers lower than 38-2606. Serial numbers of 38-2606 or higher have already been updated with software revision upgrade 4.

REASON: If the operator fails to position the diluent on the instrument, the instrument may not detect that the reagent is missing an aspirate air instead of diluent.

MANUFACTURER: MedSource - Newton Newton, Ma

PRODUCT: Z-0009-2/Z-0010-2, Heartport brand StillSite II Stabilizer, Straight Arm, A beating Heart Stabilization System

REASON: Sterility may be compromised

MANUFACTURER: Chase Medical, Inc. Athens, TX

PRODUCT: Z-0011-2, Dual Stage Venous Return Cannulae, labeled in part:

REASON: Tip may separate in use

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 10, 2001:

CLASS II

MANUFACTURER: J. T. Posey Co. Arcada, CA

PRODUCT: Z-1156-1/Z-1168-1, Patient Restraints, with locks.

REASON: Locks break open at 50 pounds pressure, specification is 100 pounds.

MANUFACTURER: MedTronic, Inc. Minneapolis, MN.

PRODUCT: Z-1169-1, Medtronic Single Chamber Temporary Pacemaker, Model 5348,

REASON: Possibility of device shutdown if the non-conforming component fails. The device would not complete the self-test routine prior to the shutdown. Another possible condition is that the battery life may not last the intended 7 days at nominal settings.

MANUFACTURER: Synthes (USA) West Chester, PA.

PRODUCT: Z-1203-1/Z-1204-1, Split Tissue Protection Sleeve.

REASON: Mislabeled protection sleeves.

MANUFACTURER: Polysciences, Inc. Warrington, PA

PRODUCT: Z-1205-1, Save-A-Tooth Emergency Tooth Preserving System. The product is shipped in cases of 24 units. A unit is a complete preserving system. The unit is a plastic jar filled with preserving solution. Codes: catalog number Z-12488-1, part number 32-393, lot number 512844

REASON: Product leaking, compromising sterility.

MANUFACTURER: DeRoyal Orthopedic Fabrication, Maynardville, TN

PRODUCT: Z-1207-1 - Examination gloves contained in the following Products:
Product name
1) Central Line DRSG Valve; 2) Dry Prep Tray;
3) Peripheral Vascular Tray; 4) Sterile O.R. Prep Tray; 5) LTC/Laparoscopy Tracepak; 6) Dr. Calhoun Lap Chole; 7) Exit Site Care Kit; 8)Pgy-Bk Peritonitis Kit; 9) Patient Prep Tray; 10) Diag. Gyn. Lapar Tracepak; 11) Dr. Danielson ACF Tracepak; 12) Cath Lab Pacemaker; 13) Dr. Pridjian Heart Tracepak; 14)Exploratory Lap Tracepak; 15) Prostatectomy Tracepak

REASON: Examination gloves in surgical kits fail leak test due to defects and holes

MANUFACTURER: CryoLife, Inc. Kennesaw, GA

PRODUCT: Z-1208-1/Z-1209-1, Allograft Heart Valve,

REASON: Donor does not meet current guidelines for serodilution of plasma.

MANUFACTURER: Remel Inc. Lenexa, KS

PRODUCT: Z-1210-1, MacConkey Agar w/ Sorbitol, Product No. 01-556, packaged 10 plates per sleeve, Codes: MacConkey Agar w/ Sorbital, Catalog No. 01-556, Lot No. 057184, Exp. Date 02-12-01

REASON: Product is mislabeled as MacConkey Agar w/ Sorbital.

MANUFACTURER: DataScope Corp.,Mahwah, NJ

PRODUCT: Z-1211-1, 18" Flat Panel Color LCD Monitor with touch screen,

REASON: In attempting to incline the monitor, the montior may tip over

MANUFACTURER: Cryolife, Inc. Kennesaw, GA

PRODUCT: Z-1214-1/Z-1215-1, Allograft Heart Valve, Model Numbers AV00 and PV00.

REASON: Donor does not meet current guidelines regarding serodilution of plasma

MANUFACTURER: Cryolife, Inc. Kennesaw, GA

PRODUCT: Z-1216-1/Z-1217-1, Allograft Heart Valve, Model Numbers AV00 and PV00

REASON: Donor does not meet current guidelines regarding serodilution of plasma

MANUFACTURER: Cryolife, Inc. Kennesaw, GA

PRODUCT: Z-1218-1/Z-1219-1, Allograft Heart Valve, Model Number AV00 and PV00,

REASON: Donor does not meet current guidelines regarding serodilution of plasma

MANUFACTURER: Cryolife, Inc. Kennesaw, GA

PRODUCT: Z-1220-1, Allograft Heart Valve, Model Number PV00.

REASON: Donor does not meet current guidelines regarding serodilution of plasma.

MANUFACTURER: Stryker Trauma Geneva, Switzerland,

PRODUCT: Z-1221-1, Monticelli Spinelli Single Action Wire Tensioner Wire Tensioner Orthopedic Manual Surgical Instrument

REASON: The internal mechanism may experience wear that eventually hinders its function

MANUFACTURER: Baxter Healthcare Corp. of Puerto Rico Aibonito, PR.

PRODUCT: Z-1222-1, Baxter Interlink System Micro-Infusion Manifold with 4-Way Stopcock and Extension Set, product code 2N3411; Baxter Healthcare Corporation, Deerfield, IL.

REASON: Pinholes in packaging compromise the sterility of the product.

MANUFACTURER: Bivona Medical Technologies, Inc. Gary, IN.

PRODUCT: Z-1224-1/Z-1226-1
A) Bivona Flextend Plus pediatric cuffless tracheostomy tube. All catalog numbers beginning with 60PFP. All lots.
B) Bivona Flextend Standard pediatric cuffless tracheostomy tube. All catalog numbers beginning with 60PFS. All lots.
C) Bivona obturators labeled for use with Bivona Flextend Plus or Flextend Standard tracheostomy tubes. All catalog numbers beginning with the letters OBT and ending with the numbers -009-3. All lots.

REASON: Obdurator tip may not be bonded to the shaft.

CLASS III

MANUFACTURER: Steris Corp. Mentor, OH

PRODUCT: Z-1155-1, Steris Quick Connect, Model C1665, is designed to process the Olympus 20D Series and BF-XT20 Bronchoscopes in STERIS SYSTEM I Sterile Processing System, with C1160 Universal Processing Tray.

REASON: The tubing in the kits are labeled with an incorrect endoscope model number.

MANUFACTURER: Becton Dickinson & Co., Broken Bow, NE

PRODUCT: Z-1213-1, BD Vacutainer Plus Plasma Separator Tube (PST) 4.5.ml 13 x 100,

REASON: Some tubes did not have required amount of Lithium Heparin

MANUFACTURER: Bayer Corporation Tarrytown, NY

PRODUCT: Z-1223-1, Software versions AE through AL (except AI) for the Bayer Advia Centaur Automated Chemiluminescence Immunoassay System. The affected software was distributed as a component of the Advia Centaur Automated Chemiluminescence Immunoassay system.

REASON: Software defect.

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